FDA.reportPublic FDA data

OrthoGold100®

Primary DI
04260484571618
Brand
OrthoGold100®
Company
MTS Medical UG (haftungsbeschränkt)
Model
OW100-US
Catalog number
1000013
Device description
The OrthoGold100® is intended for the activation of connective tissue.
Published
2019-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182682000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182682000OrthoGold 100Tissue Regeneration Technologies2018-12-21ISA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260484571618PackageGS11In Commercial Distribution
04260484571601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260484571618042604845716184260484571618
04260484571601042604845716014260484571601

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy massagerA mains electricity (AC-powered) device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. This device is intended for use in healthcare facilities and is not applicable to home therapies.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth459Millimeter
Height218Millimeter
Weight18Kilogram
Width400Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure82 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure82 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
342585299
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260484571830Dermagold100OW100S-US10000222023-09-11
04260484571694VIASUREOW100-US10000152021-07-01
4260484573018MTSLG38038000002016-09-24

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Primary DI, Brand, Company table
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