Identity
- Trade Name
- CALMING HEAT FDA UDI
- Generic Name
- Electric pad localized-body heating system FDA UDI
- Device Name
- Input DC 5V, 1A, Power 5W. CALMING HEAT Copper Charcoal Neck Wrap N&I 3 Heat ,3 Vibration, This device complies with part 15 of FCC rules. FDA UDI
- Model / Reference
- CHNSCC3-3 FDA UDI
- Description
- Input DC 5V, 1A, Power 5W. CALMING HEAT Copper Charcoal Neck Wrap N&I 3 Heat ,3 Vibration, This device complies with part 15 of FCC rules. FDA UDI
Identifiers
- Catalog Number
- CWT82004 FDA UDI
- Primary DI / UDI-DI
- 06936189900869 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
- Not 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Calming Heat by Guangdong Okay Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Guangdong Okay Technology Co., Ltd.
Sources (1)
- FDA UDI dfd30d8c-8319-4b9a-8da9-fec9c90d68ea 36 fields · synced May 30, 2026