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HiDow HD-09F

by Hi-Dow International Inc.

HiDow HD-09F is a Class II device made by Hi-Dow International Inc., cleared under FDA 510(k) K210383 on 12 Nov 2021 and listed in FDA GUDID since 22 Apr 2022 (UDI-DI 00851640007689), 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) K210383

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 Number00851640007689 UDI-DI Date22 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210383 Date12 Nov 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210383 decided 12 Nov 2021 Active
  • FDA GUDID UDI-DI 00851640007689 listed 22 Apr 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210383
  2. Listed FDA GUDID 00851640007689

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
HiDow
Generic name
Transcutaneous electrical stimulation electrode, reusable
Model / reference
HD-09F
Primary DI / UDI-DI
00851640007689
510(k) Number
FDA product code
GXY
GMDN term
Transcutaneous electrical stimulation electrode, reusable
Device class
Class II
Regulation number
882.1320
GUDID distribution status
In Commercial Distribution

Related devices

Category: Transcutaneous electrical stimulation electrode, reusable

Cleared under the same submission (K210383)

and 3 more cleared under K210383

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

Other devices from Hi-Dow International Inc.

See all devices from Hi-Dow International Inc. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)