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ReWalk Restore

by Re Walk Robotics, Ltd.

510(k) K190337

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 12 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 12 Oct 2026. What this means

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190337 Date3 Jun 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 12 Oct 2026.

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  • Withdrawn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 P6.0

    Class II