FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
RehaStim 2
K Number: K162683
·
Decision Feb 3, 2017
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
4
Review Days
130
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Basic Information
- Device Name
- RehaStim 2
- K Number
- K162683
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5810
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hasomed GmbH
- Date Received
- September 26, 2016
- Decision Date
- February 3, 2017
- Product Code
- GZI
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | FDA class 2 | Neurology |
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