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FDA 510(k)

ReWalk Restore

K-Number: K190337 · 2019-06-03

ApplicantRe Walk Robotics , Ltd.
Decision Date2019-06-03
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ReWalk Restore is a medical device manufactured by Re Walk Robotics , Ltd.. It received FDA 510(k) clearance on 2019-06-03 under approval number K190337. 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 Restore?

ReWalk Restore is a medical device that received FDA 510(k) clearance on 2019-06-03. It is manufactured by Re Walk Robotics , Ltd.. The 510(k) number is K190337.

When was ReWalk Restore approved by the FDA?

ReWalk Restore received FDA 510(k) clearance on 2019-06-03, under approval number K190337.

What company makes ReWalk Restore?

ReWalk Restore is manufactured by Re Walk Robotics , Ltd..

What is the FDA product code for ReWalk Restore?

The FDA product code for ReWalk Restore is PHL.

Other Devices by Re Walk Robotics , Ltd.

K200032ReWalk P6.0 K221696ReWalk P6.0

Related Devices (Code: PHL)

K160987ReWalk(TM)Rewalk Robotics, Inc. K161443Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. K143690Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. K152416IndegoParker Hannifin Corporation K171909HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc. K171334IndegoParker Hannifin Corporation

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.

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