ReWalk® 7 Personal Exoskeleton (50-20-0005)— 510(k) K241822

Name: FDA 510(k) clearance K241822
Creator: U.S. Food and Drug Administration
Published: 2025-03-12

Substantially Equivalent

Rewalk Robotics Ltd. Dba Lifeward

FDA 510(k) clearance K241822 for ReWalk® 7 Personal Exoskeleton (50-20-0005), Substantially Equivalent on 2025-03-12. Applicant: Rewalk Robotics Ltd. Dba Lifeward. Device class: 2.

Clearance details

Applicant: Rewalk Robotics Ltd. Dba Lifeward
Product code: Code PHL
Device class: Class 2
Regulation: 21 CFR 890.3480
Advisory panel: Physical Medicine
Date received: 2024-06-24
Decision date: 2025-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam Ilit, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.