FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
ReWalk Restore
K Number: K190337
·
Decision Jun 3, 2019
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
23
Applicant Total
3
Review Days
109
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Basic Information
- Device Name
- ReWalk Restore
- K Number
- K190337
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3480
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Re Walk Robotics , Ltd.
- Date Received
- February 14, 2019
- Decision Date
- June 3, 2019
- Product Code
- PHL
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| PHL | Powered Exoskeleton | FDA class 2 | Physical Medicine |
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