K190337 is an FDA 510(k) clearance for the ReWalk Restore. This device is classified as a Powered Exoskeleton (Class II - Special Controls, product code PHL).
Submitted by Re Walk Robotics , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on June 3, 2019, 109 days after receiving the submission on February 14, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.3480. 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..
| 510(k) Number | K190337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2019 |
| Decision Date | June 03, 2019 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PHL - Powered Exoskeleton |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3480 |
| Definition | 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. |