ReWalk P6.0— 510(k) K221696

Substantially Equivalent

Re Walk Robotics , Ltd.

FDA 510(k) clearance K221696 for ReWalk P6.0, Substantially Equivalent on 2023-03-02. Applicant: Re Walk Robotics , Ltd.. Device class: 2.

Clearance details

Applicant: Re Walk Robotics , Ltd.
Product code: Code PHL
Device class: Class 2
Regulation: 21 CFR 890.3480
Advisory panel: Physical Medicine
Date received: 2022-06-10
Decision date: 2023-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.