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EvoWalk 1.0

by Evolution Devices, Inc.

EvoWalk 1.0 is a gait-enhancement electrical stimulation system (FDA Class II; FDA product code GZI, Stimulator, Neuromuscular, External Functional) made by Evolution Devices, Inc., cleared under FDA 510(k) K230997 on 28 Dec 2023 and listed in FDA GUDID since 6 Aug 2025 (UDI-DI 00860011699309), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K230997

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860011699309 UDI-DI Date6 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK230997 Date28 Dec 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230997 decided 28 Dec 2023 Active
  • FDA GUDID UDI-DI 00860011699309 listed 6 Aug 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K230997
  2. Listed FDA GUDID 00860011699309

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EvoWalk
Generic name
Gait-enhancement electrical stimulation system, external
Model / reference
1.0
Primary DI / UDI-DI
00860011699309
510(k) Number
FDA product code
GZI
GMDN term
Gait-enhancement electrical stimulation system, external
Device class
Class II
Regulation number
882.5810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gait-enhancement electrical stimulation system, external

Similar devices

Other devices filed under FDA product code GZI (Stimulator, Neuromuscular, External Functional).

Other devices from Evolution Devices, Inc.

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)