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The Electrode Store 62057

by Impulse Medical Technologies, Inc.

The Electrode Store 62057 is a Class II device made by Impulse Medical Technologies, Inc., cleared under FDA 510(k) K020910 on 19 Jul 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00816022022094), 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) K020910

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 Number00816022022094 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020910 Date19 Jul 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020910 decided 19 Jul 2002 Active
  • FDA GUDID UDI-DI 00816022022094 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020910
  2. Listed FDA GUDID 00816022022094

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
The Electrode Store
Generic name
Subdermal needle electrode
Model / Ref / Catalog
62057
Primary DI / UDI-DI
00816022022094
510(k) Number
FDA product code
GXZ
GMDN term
Subdermal needle electrode
Device class
Class II
Regulation number
882.1350
GUDID distribution status
In Commercial Distribution

Related devices

Category: Subdermal needle electrode

Cleared under the same submission (K020910)

and 8 more cleared under K020910

Other devices from Impulse Medical Technologies, Inc.

  • DPNCheck NC-030

    Class II

  • DPNCheck NC-040

    Class II

  • DPNCheck NC-040-C

    Class II

  • DPNCheck DB-050-C

    Class II

See all devices from Impulse Medical Technologies, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)