Identity
- Trade Name
- AUVON FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- It is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremities (arm),and lower extremities (leg) due to strain from exercise or normal household work activities. It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. FDA UDI
- Model / Reference
- AS8012 FDA UDI
- Description
- It is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder,waist,back,upper extremities (arm),and lower extremities (leg) due to strain from exercise or normal household work activities. It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970890320370 FDA UDI
- 510(k) Number
- K143268 FDA UDI
- FDA Product Code
- NUH FDA UDINGX FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical 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
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
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Auvon by Shenzhen As-Tec Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Physical therapy transcutaneous neuromuscular electrical stimulation system.
- COMPEX — DJO, LLC · Class II
- RS-4s Muscle Stimulator System (R) — Rs Medical · Class II
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- veicomtech — Guangzhou Huakai Electronic Technology Co., Ltd. · Class II
- Therapist’s Choice® TENS2N1 Combo — CLINICAL HEALTH SERVICES, INC. · Class II
- iSelfCare — HEALTHMATE INTERNATIONAL, LLC · Class II
- JMOON — Shenzhen Ulike Smart Electronics Co., Ltd. · Class II
- Belifu — Hong Qiangxing (Shenzhen) Electronics Limited · Class II
Cleared under the same submission
K143268 also covers:
- Easy@Home Mini Electronic Pulse Stimulator — EASY HEALTHCARE CORPORATION
- Easy@Home Mini Electronic Pulse Stimulator — EASY HEALTHCARE CORPORATION
- Easy@Home Mini Wireless TENS Pulse Stimulator — EASY HEALTHCARE CORPORATION
- Easy@Home TENS AND MUSCLE STIMULATOR — EASY HEALTHCARE CORPORATION
- Easy@Home TENS and Powered Muscle Stimulator — EASY HEALTHCARE CORPORATION
- MEDVICE — GURIN PRODUCTS LLC
- Utopia Gear — MIDWESTERN SOLUTIONS
- Utopia Gear — MIDWESTERN SOLUTIONS
- AUVON — Shenzhen As-Tec Technology Co., Ltd.
- AUVON — Shenzhen As-Tec Technology Co., Ltd.
- AUVON — Shenzhen As-Tec Technology Co., Ltd.
- AUVON — Shenzhen As-Tec 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 As-Tec Technology Co., Ltd.
Sources (1)
- FDA UDI 31449c5a-b507-4d00-a8a6-ee73ce476fed 35 fields · synced May 30, 2026