Identity
- Trade Name
- AUVON FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use. FDA UDI
- Model / Reference
- EB1M20 FDA UDI
- Description
- The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971292002420 FDA UDI
- 510(k) Number
- K160138 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
Auvon by Shenzhen Yuwen E-Commerce Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transcutaneous electrical stimulation electrode, single-use.
- Eswallow — COMPASS HEALTH BRANDS CORP. · Class II
- TMR-ELEC-20003221 2" WH Round electrode — Emsi · Class II
- Medical Science Products — SAUVRE INTERNATIONAL, LTD. · Class II
- AdvanTrode — PEPIN MANUFACTURING, INC. · Class II
- 3x5 fabric conductive pad — BioMedical Life Systems Inc. · Class II
- MediMax Tech — MEDIMAX TECH INC. · Class II
- ProPatch — PRO MEDICAL SUPPLIES, INC. · Class II
- SuperStim Electrodes — COMPASS HEALTH BRANDS CORP. · Class II
Cleared under the same submission
K160138 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Yuwen E-Commerce Co., Ltd.
Sources (1)
- FDA UDI b1ba58fb-656d-40fb-aae6-f4a6f26126fb 34 fields · synced Jun 8, 2026