Identity
- Trade Name
- BioGel Velcro Electrode FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Cutaneous Electrode Pair 1.25” x 1.25” FDA UDI
- Model / Reference
- 2 FDA UDI
- Description
- Cutaneous Electrode Pair 1.25” x 1.25” FDA UDI
Identifiers
- Catalog Number
- 115P FDA UDI
- Primary DI / UDI-DI
- B367115P20 FDA UDI
- 510(k) Number
- K141342 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
BioGel Velcro Electrode by Axiobionics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K141342 also covers:
- Adhesive Electrode — Axiobionics, LLC
- Bilateral LE BioSleeves — Axiobionics, LLC
- BioBelt Ab — Axiobionics, LLC
- BioBelt Ab Large Expanded — Axiobionics, LLC
- BioBelt Lumbar — Axiobionics, LLC
- BioBelt Lumbar Contoured — Axiobionics, LLC
- BioBrief — Axiobionics, LLC
- BioCollar — Axiobionics, LLC
- BioGel Velcro Electrode — Axiobionics, LLC
- BioGel Velcro Electrode — Axiobionics, LLC
- BioGel Velcro Electrode — Axiobionics, LLC
- BioGel Velcro Electrode — Axiobionics, 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
- Axiobionics, LLC
Sources (1)
- FDA UDI 3ae5befe-7ed4-4132-9262-18324ea1109c 35 fields · synced May 30, 2026