← Back to catalogue
Transcutaneous Electrical Nerve Stimulator
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Z12062885
Identity
- Trade Name
- Transcutaneous Electrical Nerve Stimulator EUDAMEDPowered Muscle Stimulator FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Transcutaneous Electrical Nerve Stimulators EUDAMED
- Model / Reference
- Z12062885 EUDAMEDKTR-230W FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06924607701228 EUDAMEDFDA UDI
- Basic UDI-DI
- 69246077022497B EUDAMED
- 510(k) Number
- K181728 FDA UDI
- FDA Product Code
- NGX FDA UDI
- EMDN Code
- Z12062885 NEUROMUSCULAR STIMULATION EQUIPMENT - CONSUMABLES 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 UDI
- Market of Registration
- France 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Transcutaneous Electrical Nerve Stimulator by Shenzhen Kentro Medical Electronics Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69246077022497B | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Kentro Medical Electronics CO., LTD.
- EUDAMED SRN
- CN-MF-000011247
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED c63bad24-fa90-442c-8b4c-066b1763c4ae 61 fields · synced Jul 8, 2026
- FDA UDI dba674d7-571e-4881-88e8-21d8d53e2db6 33 fields · synced May 25, 2026