FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ekso (version 1.1) and Ekso GT (version 1.2)
K Number: K143690
·
Decision Apr 1, 2016
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
23
Applicant Total
4
Review Days
464
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Basic Information
- Device Name
- Ekso (version 1.1) and Ekso GT (version 1.2)
- K Number
- K143690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3480
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ekso Bionics, Inc.
- Date Received
- December 24, 2014
- Decision Date
- April 1, 2016
- 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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