Identity
- Trade Name
- AUVON FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- TENS: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. PMS:It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. FDA UDI
- Model / Reference
- AS1080 FDA UDI
- Description
- TENS: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. PMS: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
- 06970890320554 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
- BodyMed — BOXOUT, LLC · Class II
- 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 b811059b-5e9d-4baf-aee7-e4e550c34def 35 fields · synced May 30, 2026