Identity
- Trade Name
- Dr. Senst EUDAMEDFDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- TENS and Muscle stimulator EUDAMEDused for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back,neck,upper extremities(arm), and lower extremities( leg), due to strain from exercise or normal household and work activities. FDA UDI
- Model / Reference
- AS1080 EUDAMEDFDA UDI
- Description
- used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back,neck,upper extremities(arm), and lower extremities( leg), due to strain from exercise or normal household and work activities. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970890320486 EUDAMEDFDA UDI
- Basic UDI-DI
- 06970890321080TE EUDAMED
- 510(k) Number
- K200727 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
No
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
Dr. Senst by Shenzhen AsTec Technology Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 06970890321080TE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen AsTec Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000031961
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED ff9da10b-19dc-4c04-abcb-9851953f5c42 61 fields · synced Aug 1, 2026
- FDA UDI 1a043e60-1b64-4f79-92eb-ea228d451ba9 34 fields · synced May 30, 2026