ReWalk P6.0— 510(k) K200032

Substantially Equivalent

Re Walk Robotics , Ltd.

FDA 510(k) clearance K200032 for ReWalk P6.0, Substantially Equivalent on 2020-05-26. 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: 2020-01-07
Decision date: 2020-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

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More clearances from Re Walk Robotics , Ltd.

K221696 — ReWalk P6.02023-03-02
K190337 — ReWalk Restore2019-06-03

Recalls naming K200032

K-number listed on FDA's recall record

Z-1553-2021 — ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.Class II·Terminated·Argo Medical Technologies Ltd·20200228

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200032.

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