Identity
- Trade Name
- RehaStim2 FDA UDI
- Generic Name
- Gait-enhancement electrical stimulation system, external FDA UDI
- Device Name
- External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician. - manufactured for use in system FDA UDI
- Model / Reference
- FES01092 FDA UDI
- Description
- External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician. - manufactured for use in system FDA UDI
Identifiers
- Catalog Number
- FES01092 FDA UDI
- Primary DI / UDI-DI
- 04260397620410 FDA UDI
- 510(k) Number
- K162683 FDA UDI
- FDA Product Code
- GZI FDA UDI
- GMDN Term
- Gait-enhancement electrical stimulation system, external FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5810 FDA UDI
- Commercial Distribution
- 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
Category: Gait-enhancement electrical stimulation system, external
RehaStim2 by HASOMED GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 0795162a-6b9a-425f-a88b-ea9457117ed4 35 fields · synced May 31, 2026