AKUPORT M-2

K020568 · Vibrant Health · GZO · Apr 30, 2002 · Neurology

Device Facts

• Record ID: K020568
• Device Name: AKUPORT M-2
• Applicant: Vibrant Health
• Product Code: GZO · Neurology
• Decision Date: Apr 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1540
• Device Class: Class 2

Intended Use

Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin. There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities.

Device Story

The Akuport M-2 is a galvanic skin response measurement device. It functions by measuring the electrical resistance of the skin and tissue path between two electrodes applied to the patient's skin. The device provides a measurement of skin resistance to determine autonomic responses as physiological indicators. It does not provide diagnostic capabilities or claims regarding the clinical usefulness of the obtained data. It is intended for use by healthcare professionals to acquire physiological data.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Galvanic skin response measurement device; utilizes two electrodes to measure electrical resistance of skin and tissue path. Class II device. Product code GZO.

Indications for Use

Indicated for the measurement of skin resistance to determine autonomic responses as physiological indicators in patients. No specific patient population, age, or disease state specified. No diagnostic claims.

Regulatory Classification

Identification

A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

Submission Summary (Full Text)

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Image /page/0/Picture/1 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 an abstract symbol that resembles an eagle or bird in flight, with stylized wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2002

Mr. Stephen Emond President Vibrant Health D/O 1182508 Ontario Ltd 150 Des Grands Coteaux Beloeil, Quebec Canada, J3G 2C9

Re: K020568

Trade/Device Name: Akuport M-2 Regulation Number: 882.1540 Regulation Name: Galvanic skin response measurement device Regulatory Class: II Product Code: GZO Dated: February 11, 2002 Received: February 20, 2002

Dear Mr. Emond:

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

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Page 2 - Mr. Stephen Emond

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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.

uriam C. Provost

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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## 510 (k) #: K020568 Product: Akuport M-2

## Indications For Use:

## Galvanic Skin Response

Measurement of skin resistance to determine autonomic responses as physiological indicators by measuring the electric resistance of the skin and tissue path between 2 electrodes applied to the skin.

There are no claims as for the usefulness of the data obtained by the device, nor any specific diagnosis capabilities.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K0206568