KIMSTIM AURICULAR ELECTRODE

K011691 · Kim Institute For Rehabilitation Medicine, P.C. · GXY · Dec 27, 2001 · Neurology

Device Facts

• Record ID: K011691
• Device Name: KIMSTIM AURICULAR ELECTRODE
• Applicant: Kim Institute For Rehabilitation Medicine, P.C.
• Product Code: GXY · Neurology
• Decision Date: Dec 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The KimStim Auricular Electrode is designed as an accessory device intended to be used as an electro-acupuncture device. It is designed for a single patient use and is reuseable. General warnings, precautions, contraindications and hazards are as directed and associated with the specific TENS generators to be used by the patient.

Device Story

KimStim Auricular Electrode functions as an accessory to TENS generators for electro-acupuncture. Device delivers electrical stimulation to auricular points; input provided by external TENS generator. Used in clinical or home settings under guidance of TENS generator instructions. Output is electrical current applied to patient via auricular electrode. Benefits include localized stimulation for therapeutic purposes. Device is reusable for single-patient use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Auricular electrode accessory; reusable; single-patient use. Interfaces with TENS generators for electrical stimulation. No specific materials or software algorithms described.

Indications for Use

Indicated for use as an accessory to TENS generators for electro-acupuncture therapy. Patient population and contraindications are those associated with the specific TENS generator used.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

DEC 2 7 2001

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized design of an eagle or bird-like figure, composed of three curved lines that suggest the head and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kim Institute for Rehabilitation Medicine, P.C. C/O Donald F. Grabarz Managing Director International Regulatory Consultants, L.C. Mid Valley Professional Plaza 7651 S. 700 West, Suite 105 Salt Lake City, Utah 84047-7101

Re: K011691/S1

Trade/Device Name: KimStim Auricular Electrode Regulation Number: 21 CFR 882.1320 and Unclassified Regulation Name: Cutaneous Electrode and Electro-Acupuncture Regulatory Class: Class II Product Code: GXY and BWK Dated: October 11, 2001 Received: October 15, 2001

Dear Mr. Grabarz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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## Page 2 - Mr. Donald F. Grabarz

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality bytvelles (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse organizatial equivalence of your device of your device to a legally premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific acres on of for in vitro diagnostic devices), please contact the Office of adultionally 21 Of I F I ar 659. Additionally, for questions on the promotion and advertising of Compinance at [phone] Office of Compliance at [phone]. Also, please note the your device, picaso commovand o by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

R. Mark A. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:_

Indications For Use:

510(k) Number: K011691 Supplement: December 19, 2001

## Intended Use (Indications for Use):

The KimStim Auricular Electrode is designed as an accessory device intended to be used as The KimStilli Autonal Electrode is assigned in an eversionized for a single patient use and is reuseable.

General warnings, precautions, contraindications and hazards are as directed and associated with the specific TENS generators to be used by the patient.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milliman

Division of General, Restorative and Neurological Devices KO11691

510(k) Number_

(Optional Format 3-10-98)