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ReWalk(TM)

by Rewalk Robotics, Inc.

510(k) K160987

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK160987 Date22 Jul 2016ClearedStatusActive

Recalls

2 recalls · 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.

    • Terminated Z-0944-2018 FDA Class II initiated 14 Aug 2017

    Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.

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  • Withdrawn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
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 Restore

    Class II

  • ReWalk P6.0

    Class II