Identity
- Trade Name
- AUVON FDA UDI
- Generic Name
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
- Device Name
- TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance FDA UDI
- Model / Reference
- TA2224 FDA UDI
- Description
- TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971292002994 FDA UDI
- 510(k) Number
- K223825 FDA UDI
- FDA Product Code
- NUH FDA UDINGX FDA UDI
- GMDN Term
- Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Analgesic transcutaneous electrical nerve stimulation system
Auvon by Shenzhen Yuwen E-Commerce Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Analgesic transcutaneous electrical nerve stimulation system.
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- Transcutaneous Electrical Nerve Stimulators — Shenzhen Kentro Medical Electronics Co., Ltd · Class II
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- Transcutaneous Electrical Nerve Stimulators — Shenzhen Kentro Medical Electronics Co., Ltd · Class II
Cleared under the same submission
K223825 also covers:
- AUVON — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- AVCOO — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- AVCOO — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
- No — Shenzhen Jian Feng Electronic Technology Co., Ltd.
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
- Shenzhen Yuwen E-Commerce Co., Ltd.
Sources (1)
- FDA UDI 3f19c8b1-63c0-45ad-9d67-180359df314e 35 fields · synced May 30, 2026