Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 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.

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. 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.

Related Devices (Code: PHL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260381EveWandercraft SASK250904Atalante XWandercraft SASK233695Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc.K232077Atalante XWandercraft SASK221696ReWalk P6.0Re Walk Robotics , Ltd.K221859AtalanteWandercraft SAS

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.

↑