Identity
- Trade Name
- Therabody FDA UDI
- Generic Name
- Electric pad localized-body heating system FDA UDI
- Device Name
- Hot and Heat FDA UDI
- Model / Reference
- RecoveryTherm Cube FDA UDI
- Description
- Hot and Heat FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840295401782 FDA UDI
- FDA Product Code
- IRT FDA UDIIME FDA UDI
- GMDN Term
- Electric pad localized-body heating system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5740 FDA UDI890.5700 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hot/cold therapy pack, reusableElectric pad localized-body heating system
Therabody by Therabody, Inc. — 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
- Therabody, Inc.
Sources (1)
- FDA UDI b8654734-c2f1-48b8-87c7-5eae3308e6a7 33 fields · synced May 30, 2026