Identity
- Trade Name
- COMFYTENS FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- DIGITAL TENS WITH 5 MODES FDA UDI
- Model / Reference
- COMFYTENS FDA UDI
- Description
- DIGITAL TENS WITH 5 MODES FDA UDI
Identifiers
- Catalog Number
- COMFYTENS, COMFYTENS-JETT, COMFYTENS-TP, COMFYTENS-MFR FDA UDI
- Primary DI / UDI-DI
- 00816924020266 FDA UDI
- 510(k) Number
- K071951 FDA UDI
- FDA Product Code
- GZJ FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Comfytens by Tensproducts, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Tensproducts, LLC
Sources (1)
- FDA UDI c6099ba3-1bba-438b-a69a-ee277f950498 35 fields · synced Jun 6, 2026