← Back to catalogue
ReGrasp Clinician Pro 2
EUDAMEDFDA UDIClass I (EU MDR)
Ref EPKTSModel EPKV2
by Rehabtronics
Identity
- Trade Name
- ReGrasp Clinician Pro 2 EUDAMEDReGrasp FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Electronic Positioning Kit Version 2 EUDAMEDEPK Transfer Sheet FDA UDI
- Model / Reference
- EPKV2 EUDAMEDEPKTS EUDAMEDFDA UDI
- Description
- EPK Transfer Sheet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17540176030192 EUDAMEDFDA UDI
- Basic UDI-DI
- 17540176060007K4 EUDAMED
- 510(k) Number
- K153163 FDA UDI
- FDA Product Code
- IPF FDA UDIGZI FDA UDI
- EMDN Code
- Z12062880 NEUROMUSCULAR STIMULATION EQUIPMENT - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5850 FDA UDI882.5810 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
Yes
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
MR Unsafe FDA UDI
ReGrasp Clinician Pro 2 by Rehabtronics — Class I — 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 | 17540176060007K4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rehabtronics
- EUDAMED SRN
- CA-MF-000018807
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED dc121508-a79f-496f-a5dc-932831643879 61 fields · synced Jul 8, 2026
- FDA UDI 254a7ba3-646f-4137-8da3-35b7ecbfea83 34 fields · synced May 30, 2026