Identity
- Trade Name
- TENSRX FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- TENSRX SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 500/CASE FDA UDI
- Model / Reference
- NPPELE615 FDA UDI
- Description
- TENSRX SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 500/CASE FDA UDI
Identifiers
- Catalog Number
- 615 FDA UDI
- Primary DI / UDI-DI
- 00815991020346 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
Tensrx by Boxout, Llc — 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
- Boxout, Llc
Sources (1)
- FDA UDI f6bc6d12-c463-4dc3-9b39-4b43f96dd38e 35 fields · synced Jun 8, 2026