Identity
- Trade Name
- Thermophore Plus FDA UDI
- Generic Name
- Electric pad localized-body heating system FDA UDI
- Device Name
- Standard Thermophore Plus FDA UDI
- Model / Reference
- F00255 FDA UDI
- Description
- Standard Thermophore Plus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00040337002551 FDA UDI
- FDA Product Code
- IRT FDA UDI
- GMDN Term
- Electric pad localized-body heating system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5740 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
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
No
FDA UDI
Category: Electric pad localized-body heating system
Thermophore Plus by Battle Creek Equipment Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electric pad localized-body heating system.
- Walgreens — WALGREEN CO. · Class II
- HealthyLine — IMEDIA NY INC · Class II
- Rite Aid — RITE AID CORPORATION · Class II
- SHARPER IMAGE — GUANGDONG OKAY TECHNOLOGY CO., LTD. · Class II
- Sunbeam — Jarden Consumer Solutions · Class II
- AVACEN — AVACEN MEDICAL, INC · Class II
- SHARPER IMAGE — Zhejiang Lumeng Health & Technology Co., Ltd. · Class II
- All star — Zhejiang Lumeng Health & Technology Co., Ltd. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Battle Creek Equipment Co.
Sources (1)
- FDA UDI c458b3ee-0bce-4998-b031-be97848afc8b 33 fields · synced Jun 8, 2026