510(k) K190337
K190337 is an FDA 510(k) premarket notification submitted by Re Walk Robotics , Ltd. for the device "ReWalk Restore". The FDA issued a decision of Substantially Equivalent on June 3, 2019. The device falls under product code PHL (Powered Exoskeleton), a Class II device regulated under 21 CFR 890.3480. Re Walk Robotics , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2019
- Date Received
- February 14, 2019
- 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.