510(k) K161443
K161443 is an FDA 510(k) premarket notification submitted by Ekso Bionics, Inc. for the device "Ekso (version 1.1) and Ekso GT (version 1.2)". The FDA issued a decision of Substantially Equivalent on July 19, 2016. The device falls under product code PHL (Powered Exoskeleton), a Class II device regulated under 21 CFR 890.3480. Ekso Bionics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2016
- Date Received
- May 25, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powered Exoskeleton
- Device Class
- Class II
- Regulation Number
- 890.3480
- Review Panel
- NE
- Submission Type
A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes.