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ReWalk P6.0

by Re Walk Robotics, Ltd. 2 variants

510(k) K200032

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200032 Date26 May 2020ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1553-2021 FDA Class II initiated 28 Feb 2020

    ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caught fire while being charged.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PHL
FDA applicant
Re Walk Robotics , Ltd.
Device Class
Class II
Regulation
21 CFR Part 890.3480
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Other devices from Re Walk Robotics, Ltd.

  • ReWalk P6.0

    Class II

  • ReWalk(TM)

    Class II

  • ReWalk Restore

    Class II