ReWalk Restore— 510(k) K190337

Substantially Equivalent

Re Walk Robotics , Ltd.

FDA 510(k) clearance K190337 for ReWalk Restore, Substantially Equivalent on 2019-06-03. Applicant: Re Walk Robotics , Ltd..

Clearance details

Applicant: Re Walk Robotics , Ltd.
Product code: Code PHL
Advisory panel: Physical Medicine
Date received: 2019-02-14
Decision date: 2019-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

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