Identity
- Trade Name
- QuadraTENS FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- QuadraTENS dual-channel system allows you to relax two sets of muscles simultaneously. It’s ability to target both cranial nerves and large muscle groups is what separates the QuadraTENS from all other TENs systems on the market. FDA UDI
- Model / Reference
- Unit FDA UDI
- Description
- QuadraTENS dual-channel system allows you to relax two sets of muscles simultaneously. It’s ability to target both cranial nerves and large muscle groups is what separates the QuadraTENS from all other TENs systems on the market. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003499979 FDA UDI
- 510(k) Number
- K061799 FDA UDI
- FDA Product Code
- GZJ FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Analgesic transcutaneous electrical nerve stimulation system
QuadraTENS by Bio-Research Associates, Inc. — 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
- Bio-Research Associates, Inc.
Sources (1)
- FDA UDI 9f0a0c3a-0758-436e-a0a6-eff7c499d17e 35 fields · synced Jun 6, 2026