FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
REHASTIM 2, ERIGOPRO (FES)
K Number: K132416
·
Decision May 28, 2014
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
4
Review Days
299
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Basic Information
- Device Name
- REHASTIM 2, ERIGOPRO (FES)
- K Number
- K132416
- 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
- August 2, 2013
- Decision Date
- May 28, 2014
- 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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