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FDA 510(k)

ReWalk P6.0

K-Number: K221696 · 2023-03-02

ApplicantRe Walk Robotics , Ltd.
Decision Date2023-03-02
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ReWalk P6.0 is a medical device manufactured by Re Walk Robotics , Ltd.. It received FDA 510(k) clearance on 2023-03-02 under approval number K221696. 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 2023-03-02. It is manufactured by Re Walk Robotics , Ltd.. The 510(k) number is K221696.

When was ReWalk P6.0 approved by the FDA?

ReWalk P6.0 received FDA 510(k) clearance on 2023-03-02, under approval number K221696.

What company makes ReWalk P6.0?

ReWalk P6.0 is manufactured by Re Walk Robotics , Ltd..

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

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

Other Devices by Re Walk Robotics , Ltd.

K190337ReWalk Restore K200032ReWalk 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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