FDA 510(k)

ReWalk P6.0

K-Number: K200032 · 2020-05-26

Decision Date2020-05-26

Product CodePHL

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

ReWalk P6.0 is the device name listed in this FDA 510(k) record. The listed applicant is Re Walk Robotics , Ltd.. It received FDA 510(k) clearance on 2020-05-26 under 510(k) number K200032. 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 P6.0?

ReWalk P6.0 is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is Re Walk Robotics , Ltd.. The 510(k) number is K200032.

When did ReWalk P6.0 receive FDA 510(k) clearance?

ReWalk P6.0 received FDA 510(k) clearance on 2020-05-26, under 510(k) number K200032.

Who is the listed applicant for ReWalk P6.0?

The FDA 510(k) record lists Re Walk Robotics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ReWalk P6.0?

The FDA product code for ReWalk P6.0 is PHL.

Other records listing Re Walk Robotics , Ltd. as applicant

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.

K221696ReWalk P6.0 K190337ReWalk Restore

Related Devices (Code: PHL)

K260381EveWandercraft SAS K250904Atalante XWandercraft SAS K241822ReWalk® 7 Personal Exoskeleton (50-20-0005)Rewalk Robotics Ltd. Dba Lifeward K233695Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc.K232077Atalante XWandercraft SAS K221696ReWalk P6.0Re Walk Robotics , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.