Identity
- Trade Name
- RehaStim 2 / RehaMove 2 FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- powered muscle stimulator (8 channels) for use as stand-alone device as well as in combination with powered exerciser with predefined programs for stimulation of muscles of the musculoskeletal system FDA UDI
- Model / Reference
- FES00005 FDA UDI
- Description
- powered muscle stimulator (8 channels) for use as stand-alone device as well as in combination with powered exerciser with predefined programs for stimulation of muscles of the musculoskeletal system FDA UDI
Identifiers
- Catalog Number
- FES00005 FDA UDI
- Primary DI / UDI-DI
- 04260397620168 FDA UDI
- 510(k) Number
- K112844 FDA UDI
- FDA Product Code
- GZI FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5810 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
RehaStim 2 / RehaMove 2 by HASOMED GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K112844 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- HASOMED GmbH
Sources (1)
- FDA UDI 26228a7e-8c84-4474-ac30-e7801c15278c 36 fields · synced May 30, 2026