Identity
- Trade Name
- THERA Plus FDA UDI
- Generic Name
- Moist-heat pack FDA UDI
- Device Name
- TP HEAT PATCH AIR ACTIVATED 1CT FDA UDI
- Model / Reference
- 64430325A FDA UDI
- Description
- TP HEAT PATCH AIR ACTIVATED 1CT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00049696507790 FDA UDI
- FDA Product Code
- IMD FDA UDI
- GMDN Term
- Moist-heat pack FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5710 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Moist-heat pack
THERA Plus by Fourstar Group Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Moist-heat pack.
- Bed Buddy — COMPASS HEALTH BRANDS CORP. · Class I
- BIOS Living — Thermor Ltd · Class I
- HydraHeat — COMPASS HEALTH BRANDS CORP. · Class I
- HydraHeat — COMPASS HEALTH BRANDS CORP. · Class I
- COLLINS SPORTS — Asp Global, LLC · Class I
- HydraHeat — COMPASS HEALTH BRANDS CORP. · Class I
- Pure Comfort Prostate Patch — HOME AIDE DIAGNOSTICS, INC. · Class I
- Ultra Comfort Heating Patch — HOME AIDE DIAGNOSTICS, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fourstar Group Inc.
Sources (1)
- FDA UDI fcd8fe71-a67c-4a45-b521-30208b3f2029 33 fields · synced May 30, 2026