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MyndMove Functional Electrical System

by Myndtec, Inc.

MyndMove Functional Electrical System (910200) is a Class II device made by Myndtec, Inc., cleared under FDA 510(k) K170564 on 30 Aug 2017 and listed in FDA GUDID since 24 Oct 2017 (UDI-DI 06925209102000), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K170564

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 Number06925209102000 UDI-DI Date24 Oct 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170564 Date30 Aug 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170564 decided 30 Aug 2017 Active
  • FDA GUDID UDI-DI 06925209102000 listed 24 Oct 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170564
  2. Listed FDA GUDID 06925209102000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MyndMove
Generic name
Neuromuscular transmission electrode
Model / Ref / Catalog
MyndMove Functional Electrical System, 910200
Primary DI / UDI-DI
06925209102000
510(k) Number
FDA product code
IPF, GZI
GMDN term
Neuromuscular transmission electrode
Device class
Class II
Regulation number
890.5850, 882.5810
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K170564)

and 8 more cleared under K170564

Similar devices

Other devices filed under FDA product code IPF (Stimulator, Muscle, Powered).

Other devices from Myndtec, Inc.

See all devices from Myndtec, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)