Kimstim Auricular Electrode

by Kim Institute For Rehabilitation Medicine, P.C.

510(k) K011691

Active United States

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) K011691↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK011691	Date27 Dec 2001Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K011691
FDA Product Code: GXY

Device Class: Class II
Regulation: 21 CFR Part 882.1320
Advisory Committee: Neurology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Kimstim Auricular Electrode is an accessory device intended to be used as an electro-acupuncture device. It is classified under product code GXY and regulation 882.1320, with a medical specialty in neurology.

It received FDA 510(k) clearance (K011691) on December 27, 2001, as substantially equivalent through a traditional review process. The device is supplied by the Kim Institute For Rehabilitation Medicine, P.C., located in Midvale, Utah.