FDA.reportPublic FDA data

VIASURE

Primary DI
04260484571687
Brand
VIASURE
Company
MTS Medical AG
Model
OW100-US
Catalog number
1000015
Device description
Indications for UseThe VIASURE is intended for :• Relief of minor muscle aches and pains• Temporary increase in local blood circulation• Activation of connective tissue
Published
2021-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260484571694PackageGS11In Commercial Distribution
04260484571687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260484571694042604845716944260484571694
04260484571687042604845716874260484571687

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding electric massagerAn electrically-powered benchtop, mobile, or stationary device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may be in the form of a vibrating bed or a tabletop/freestanding unit with a massaging handpiece or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. 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

Contacts#

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

Regulatory Flags#

DUNS number
342585299
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260484571281ChiroGoldOW100S-US10000292025-06-30
04260484571298ChiroGoldOW100S-US10000292025-06-30
04260484571267Softwave Gold LiOW100S-US10000242024-08-30
04260484571274Softwave Gold LiOW100S-US10000242024-08-30
04260484571601OrthoGold100®OW100-US10000132019-01-23
04260484571823Dermagold100OW100S-US10000222023-09-11
04260484573001MTSLG38038000002016-09-24
04260484571625OW100SOW100S-US10000212022-11-29
04260484571649DermaGold100®OW100-US10000142020-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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