Identity
- Trade Name
- HAYSWELL FDA UDI
- Generic Name
- Electric pad localized-body heating system FDA UDI
- Device Name
- Powered heating pad. An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is normally available [non-prescription] over-the-counter (OTC) for use in the home. FDA UDI
- Model / Reference
- HP-3000 FDA UDI
- Description
- Powered heating pad. An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is normally available [non-prescription] over-the-counter (OTC) for use in the home. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860036001101 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electric pad localized-body heating system
Hayswell by Hayswell — 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
- Hayswell
Sources (1)
- FDA UDI 30ab56b0-46be-4367-b7d1-de961c32c42d 33 fields · synced Jun 8, 2026