FDA 510(k)

ReWalk® 7 Personal Exoskeleton (50-20-0005)

Número K: K241822 · 2025-03-12

RequerenteRewalk Robotics Ltd. Dba Lifeward

Data da decisão2025-03-12

Código do produtoPHL

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

ReWalk® 7 Personal Exoskeleton (50-20-0005) is the device name listed in this FDA 510(k) record. The listed applicant is Rewalk Robotics Ltd. Dba Lifeward. It received FDA 510(k) clearance on 2025-03-12 under 510(k) number K241822. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Rewalk Robotics Ltd. Dba Lifeward. The 510(k) number is K241822.

When did ReWalk® 7 Personal Exoskeleton (50-20-0005) receive FDA 510(k) clearance?

ReWalk® 7 Personal Exoskeleton (50-20-0005) received FDA 510(k) clearance on 2025-03-12, under 510(k) number K241822.

Who is the listed applicant for ReWalk® 7 Personal Exoskeleton (50-20-0005)?

The FDA 510(k) record lists Rewalk Robotics Ltd. Dba Lifeward as the applicant. This does not by itself establish the device manufacturer.

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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