Identity
- Trade Name
- Verve Deluxe FDA 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
- AS2015 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
- 06970890320547 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970890320547 EUDAMED
- 510(k) Number
- K200727 FDA UDI
- FDA Product Code
- NUH FDA UDINGX FDA UDI
- EMDN Code
- N010299 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
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
MR Unsafe FDA UDI
Tens and Muscle stimulator by Shenzhen AsTec Technology Co., Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970890320547 | 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 d0bafd9a-df46-46da-8409-dd732f9f6bf5 61 fields · synced Jul 10, 2026
- FDA UDI 010d4cdb-5caa-4c60-b77d-707df299cdef 35 fields · synced May 30, 2026