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MyndStep Lead Wire

by Myndtec, Inc.

MyndStep Lead Wire (800113) is a Class II device made by Myndtec, Inc., cleared under FDA 510(k) K202110 on 5 Nov 2021 and listed in FDA GUDID since 16 Sep 2022 (UDI-DI 00692520001133), 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) K202110

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 Number00692520001133 UDI-DI Date16 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202110 Date5 Nov 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202110 decided 5 Nov 2021 Active
  • FDA GUDID UDI-DI 00692520001133 listed 16 Sep 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K202110
  2. Listed FDA GUDID 00692520001133

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MyndStep
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / Ref / Catalog
MyndStep Lead Wire, 800113
Primary DI / UDI-DI
00692520001133
510(k) Number
FDA product code
GZI, IPF
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class II
Regulation number
882.5810, 890.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Physical therapy transcutaneous neuromuscular electrical stimulation system

Cleared under the same submission (K202110)

and 1 more cleared under K202110

Similar devices

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

Other devices from Myndtec, Inc.

See all devices from Myndtec, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)