EAV COMBI-2

K020565 · Vibrant Health · GZO · Apr 30, 2002 · Neurology

Device Facts

• Record ID: K020565
• Device Name: EAV COMBI-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

EAV Combi-2 measures skin resistance to assess autonomic responses. Device utilizes two electrodes applied to patient skin to measure electrical resistance of skin and tissue path. Device provides raw resistance data; no diagnostic capabilities or clinical utility claims are made. Intended for use by healthcare professionals to obtain physiological indicators.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Galvanic skin response measurement device. Operates by measuring electrical resistance between two skin-applied electrodes. Class II device.

Indications for Use

Indicated for the measurement of skin resistance to determine autonomic responses as physiological indicators. No specific patient population, age, or disease state is defined. 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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of a human figure with outstretched arms, resembling a bird in flight. The figure is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

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: K020565

Trade/Device Name: EAV Combi-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 We have reviewed your Section 910(x) promatice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars actiment date of the Medical Device Amendments, or to commerce prior to May 26, 1976, the exactitions of the Federal Food. Drug, devices that have occh recassinod in accee approval of a premarket approval application (PMA). and Cosmette Act (10t) that to her requent to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the 110 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 II your device is classified (600 above) and Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of t thay be subject to such additions, 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 Frease oc advised that I Dris issuantes virth other requirements of the requirements of the Act that I Dri has made a collinistered by other Federal agencies. You must of any I could statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fart 6077, laceming (21 CFR Part 820); and if applicable, the electronic forth in the quality by well be (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) This letter will and w yourse FDA finding of substantial equivalence of your device to a legally promation wolfication. The side 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 arris 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CHC Fat 807.10 Idditionally, for questions on the promotion and advertising of Compinance at (301) 59 + 165 Office of Compliance at [phone]. Also, please note the your de roos, product "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oinor 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,

Muriam C. Provost

Col 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) #: K020565 EAV Combi-2 Product:

## 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)

Musiam C. Provost

on of General, Restorative and Neurological Devic

510(k) Number k020565