Identity
- Trade Name
- TENSTRODE FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- 2" X 2" SQUARE TAN CLOTH ELECTRODE POLY BAG 4/PK FDA UDI
- Model / Reference
- KWTS22-MFR FDA UDI
- Description
- 2" X 2" SQUARE TAN CLOTH ELECTRODE POLY BAG 4/PK FDA UDI
Identifiers
- Catalog Number
- KWTS22-MFR FDA UDI
- Primary DI / UDI-DI
- 00850209007009 FDA UDI
- 510(k) Number
- K012463 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
Tenstrode by Medical Finance Resources Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K012463 also covers:
- Protekt Titanium Adhesive Pre-Gelled Electrode for TENS - Rectangular 2"x4" — Proactive Medical Products
- Protekt Titanium Adhesive Pre-Gelled Electrode for TENS - Round 2" — Proactive Medical Products
- Protekt Titanium Adhesive Pre-Gelled Electrode for TENS - Round 3" — Proactive Medical Products
- Protekt Titanium Adhesive Pre-Gelled Electrode for TENS - Square 2"x2" — Proactive Medical Products
- TENSPRODUCTS/TENSTRODE — Tensproducts, LLC
- TENSPRODUCTS/TENSTRODE — Tensproducts, LLC
- TENSPRODUCTS/TENSTRODE — Tensproducts, LLC
- TENSPRODUCTS/TENSTRODE — Tensproducts, LLC
- TENSPRODUCTS/TENSTRODE — Tensproducts, LLC
- TENSPRODUCTS/TENSTRODE — Tensproducts, LLC
- TENSPRODUCTS/TENSTRODE — Tensproducts, LLC
- TENSPRODUCTS/TENSTRODE — Tensproducts, LLC
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
- Medical Finance Resources Inc
Sources (1)
- FDA UDI 9d950dd3-a11a-4fc7-843a-4f257cdd8238 36 fields · synced Jun 8, 2026