Identity
- Trade Name
- Brace Direct FDA UDI
- Generic Name
- Circulating-fluid localized thermal therapy system FDA UDI
- Device Name
- Experience fast relief from muscle and joint pain with our state-of-the-art Frozen Ice Cold Therapy Machine. The ergonomic therapy pad provides comprehensive coverage, targeting areas like the knee, ankle, shoulder, and more, ensuring deep therapeutic comfort. FDA UDI
- Model / Reference
- CTY194-Unit-Plus-Uni-Pad FDA UDI
- Description
- Experience fast relief from muscle and joint pain with our state-of-the-art Frozen Ice Cold Therapy Machine. The ergonomic therapy pad provides comprehensive coverage, targeting areas like the knee, ankle, shoulder, and more, ensuring deep therapeutic comfort. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00686162753284 FDA UDI
- FDA Product Code
- ILO FDA UDI
- GMDN Term
- Circulating-fluid localized thermal therapy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5720 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Circulating-fluid localized thermal therapy system
Brace Direct by Brace Align — 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
- Brace Align
Sources (1)
- FDA UDI 0de3e785-187e-41b3-915d-ae3b97da0af9 33 fields · synced Jun 1, 2026