OrthoGold100® 1000013

GUDID 04260484571618

The OrthoGold100® is intended for the activation of connective tissue.

MTS Medical UG (haftungsbeschränkt)

Physical therapy massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager

Primary Device ID	04260484571618
NIH Device Record Key	b0fd3628-c2a6-4874-8ad3-6e035459b137
Commercial Distribution Status	In Commercial Distribution
Brand Name	OrthoGold100®
Version Model Number	OW100-US
Catalog Number	1000013
Company DUNS	342585299
Company Name	MTS Medical UG (haftungsbeschränkt)
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com
Phone	(404) 402-6844
Email	info@trtllc.com

Device Dimensions

Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter
Weight	18 Kilogram
Depth	459 Millimeter
Width	400 Millimeter
Height	218 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 82 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260484571601 [Primary]
GS1	04260484571618 [Package] Contains: 04260484571601 Package: Box [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182682

FDA Product Code

ISA	Massager, Therapeutic, Electric

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-02-25
Device Publish Date	2019-01-23

Devices Manufactured by MTS Medical UG (haftungsbeschränkt)

04260484571830 - Dermagold100	2023-09-19 The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer w
04260484571625 - OW100S	2022-12-07 Indications for Use The OW100S (model OW100S-US) is intended for: - Relief of minor muscle aches and pains - Temporary increase
04260484571694 - VIASURE	2021-07-09 Indications for Use The VIASURE is intended for : • Relief of minor muscle aches and pains • Temporary increase in local blo
04260484571649 - DermaGold100®	2020-04-08 The DermaGold100® is intended for treatment of diabetic footulcers
4260484573018 - MTS	2020-04-01 The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold®
04260484571618 - OrthoGold100®	2019-02-25The OrthoGold100® is intended for the activation of connective tissue.
04260484571618 - OrthoGold100®	2019-02-25 The OrthoGold100® is intended for the activation of connective tissue.