ReWalk® 7 Personal Exoskeleton (50-20-0005)
K-Number: K241822 · 2025-03-12
ApplicantRewalk Robotics Ltd. Dba Lifeward
Decision Date2025-03-12
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
ReWalk® 7 Personal Exoskeleton (50-20-0005) is a medical device manufactured by Rewalk Robotics Ltd. Dba Lifeward. It received FDA 510(k) clearance on 2025-03-12 under approval number K241822. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ReWalk® 7 Personal Exoskeleton (50-20-0005)?
ReWalk® 7 Personal Exoskeleton (50-20-0005) is a medical device that received FDA 510(k) clearance on 2025-03-12. It is manufactured by Rewalk Robotics Ltd. Dba Lifeward. The 510(k) number is K241822.
When was ReWalk® 7 Personal Exoskeleton (50-20-0005) approved by the FDA?
ReWalk® 7 Personal Exoskeleton (50-20-0005) received FDA 510(k) clearance on 2025-03-12, under approval number K241822.
What company makes ReWalk® 7 Personal Exoskeleton (50-20-0005)?
ReWalk® 7 Personal Exoskeleton (50-20-0005) is manufactured by Rewalk Robotics Ltd. Dba Lifeward.
What is the FDA product code for ReWalk® 7 Personal Exoskeleton (50-20-0005)?
The FDA product code for ReWalk® 7 Personal Exoskeleton (50-20-0005) is PHL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.