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Auvon
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AS9020EModel AS1080, AS8012,AS8018,AS8012C,AS8016,AS8012B,AS8011,AS8015,AS2015,AS8019, AS9020, AS2080,AS9026,AS9034,AS9020E AS9038（ViaMed),AS2016(IonMedx) AS9022 AS2503B AS9024AS9035
Identity
- Trade Name
- AUVON EUDAMEDFDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- TENS and Muscle stimulator EUDAMEDTENS: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, AS8012,AS8018,AS8012C,AS8016,AS8012B,AS8011,AS8015,AS2015,AS8019, AS9020, AS2080,AS9026,AS9034,AS9020E AS9038（ViaMed),AS2016(IonMedx) AS9022 AS2503B AS9024AS9035 EUDAMEDAS9020E EUDAMEDAS8012 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
- 06970890320714 EUDAMED06970890320660 FDA UDI
- Basic UDI-DI
- 0697089032TENSA6 EUDAMED
- 510(k) Number
- K143268 FDA UDI
- FDA Product Code
- NUH FDA UDINGX FDA UDI
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
Auvon by Shenzhen As-Tec Technology Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI e9095bd4-a8f4-406d-a9c2-ace2dcad2606 36 fields · synced Aug 4, 2026
- EUDAMED 55725a96-65e3-4155-949b-0ce16f983eb0 61 fields · synced Aug 4, 2026