Identity
- Trade Name
- AURAWAVE FDA UDI
- Generic Name
- Arthritis TENS system FDA UDI
- Device Name
- T.E.N.S. Device ; Pain Relief Therapy Kit. FDA UDI
- Model / Reference
- AWDD FDA UDI
- Description
- T.E.N.S. Device ; Pain Relief Therapy Kit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628055644002 FDA UDI
- FDA Product Code
- GXY FDA UDINUH FDA UDINYN FDA UDI
- GMDN Term
- Arthritis TENS system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI882.5890 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
Yes
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Arthritis TENS system
Aurawave by Endurance Therapeutics — 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
- Endurance Therapeutics
Sources (1)
- FDA UDI 490fdbe2-b0f4-47fb-b45b-e3e3e76db098 34 fields · synced May 30, 2026