Submission Details
| 510(k) Number | K241822 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 24, 2024 |
| Decision Date | March 12, 2025 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
ReWalk? 7 Personal Exoskeleton (50-20-0005)
Mar 2025
Decision
261d
Days
Class 2
Risk
About This 510(k) Submission
K241822 is an FDA 510(k) clearance for the ReWalk? 7 Personal Exoskeleton (50-20-0005), a Powered Exoskeleton (Class II — Special Controls, product code PHL), submitted by Rewalk Robotics Ltd. Dba Lifeward (Yokneam Ilit, IL). The FDA issued a Cleared decision on March 12, 2025, 261 days after receiving the submission on June 24, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.
Device Classification
| 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. |
Manufacturer
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