← Back to catalogue
Tens and Muscle stimulator
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref AS8012BRef AS2080Ref AS9038Model AS1080, AS8012,AS8018,AS8012C,AS8016,AS8012B,AS8011,AS8015,AS2015,AS8019, AS9020, AS2080,AS9026,AS9034,AS9020E AS9038（ViaMed),AS2016(IonMedx) AS9022 AS2503B AS9024AS9035Ref AS9034
Identity
- Trade Name
- No Brand FDA UDIVicsainteck FDA 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
- AS8012B EUDAMEDAS9034 EUDAMEDFDA UDIAS2080 EUDAMEDFDA UDIAS1080, AS8012,AS8018,AS8012C,AS8016,AS8012B,AS8011,AS8015,AS2015,AS8019, AS9020, AS2080,AS9026,AS9034,AS9020E AS9038（ViaMed),AS2016(IonMedx) AS9022 AS2503B AS9024AS9035 EUDAMEDAS9038 EUDAMED
- 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
- 06970890320691 EUDAMED06970890320349 EUDAMEDFDA UDI06970890320745 EUDAMED06970890320738 EUDAMED06970890320585 FDA UDI
- Basic UDI-DI
- B-06970890320691 EUDAMED06970890322080TM EUDAMED0697089032TENSA6 EUDAMED
- 510(k) Number
- K143268 FDA UDI
- FDA Product Code
- NGX FDA UDINUH FDA UDI
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMEDN010299 NEUROLOGIC PHYSIOTHERAPHY DEVICES - OTHER EUDAMED
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5890 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 UDIFDA 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 UDIFDA UDI
Tens and Muscle stimulator by Shenzhen AsTec Technology Co., Ltd — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06970890320691 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K200727 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06970890320691 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen AsTec Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000031961
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (7)
- EUDAMED 3afcb0c8-cef5-4c0a-9657-5a7a7e0a44fe 61 fields · synced Aug 3, 2026
- FDA UDI 78898af6-3db5-4893-94b5-c93f50c37f22 35 fields · synced May 29, 2026
- FDA UDI 64153aaa-98e4-4929-8dd7-3dd4184682a7 33 fields · synced May 30, 2026
- EUDAMED 7a776796-fbdb-4901-acdb-3c45ddd5e33b 61 fields · synced Jun 20, 2026
- EUDAMED 8afe9554-bb02-4759-9d59-7d3004639e3b 61 fields · synced Jul 21, 2026
- EUDAMED 39a34de1-01c8-42fd-9bb5-d9dea794e8df 61 fields · synced Aug 3, 2026
- FDA 510(k) K200727 1 fields · synced May 18, 2026