Identity
- Trade Name
- GB-3 FDA UDI
- Generic Name
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
- Device Name
- Model GB-3 Device emits heat from the heater and treats the afflicted part of the body, hands, legs, knee, shoulder etc. by placing it near the surface of the bare skin (at a distance directly over the skin surface). It is effective when deep heating of body tissue is desired. FDA UDI
- Model / Reference
- GD5208 FDA UDI
- Description
- Model GB-3 Device emits heat from the heater and treats the afflicted part of the body, hands, legs, knee, shoulder etc. by placing it near the surface of the bare skin (at a distance directly over the skin surface). It is effective when deep heating of body tissue is desired. FDA UDI
Identifiers
- Catalog Number
- GD5208 FDA UDI
- Primary DI / UDI-DI
- 14897076720146 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Musculoskeletal infrared phototherapy unit, non-wearable
Gb-3 by Tens Plus Industrial Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tens Plus Industrial Company
Sources (1)
- FDA UDI 6a46edf0-2559-4091-bf54-9e88d891f6b9 35 fields · synced Jun 7, 2026