PHAZX VLD-100

K992129 · Phazx Systems, Inc. · GZO · Sep 17, 1999 · Neurology

Device Facts

• Record ID: K992129
• Device Name: PHAZX VLD-100
• Applicant: Phazx Systems, Inc.
• Product Code: GZO · Neurology
• Decision Date: Sep 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1540
• Device Class: Class 2

Intended Use

measurement of galvanic skin resistance, for biofeedback information

Device Story

VLD-100 measures galvanic skin resistance (GSR) to provide biofeedback data. Device operates by monitoring electrical skin conductance changes; outputs are used for biofeedback applications. Intended for use in clinical or professional settings to assist in stress management or relaxation training. Healthcare providers interpret GSR output to guide patient biofeedback sessions, potentially aiding in physiological self-regulation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Device measures galvanic skin resistance. Technical specifications, materials, and connectivity details are not provided in the source document.

Indications for Use

Indicated for the measurement of galvanic skin resistance for the purpose of providing biofeedback information to users.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1999

Phazx Systems, Inc. c/o Lewis W. Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado 80301

Re: K992129 Trade Name: VLD-100 Regulatory Class: II Product Code: GZO Dated: June 9, 1999 Received: June 23, 1999

Dear Mr. Ward:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Lewis W. Ward

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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## Initial 510(k):K 99 2129

Device Name: VLD-100

Indications for Use: measurement of galvanic skin resistance, for biofeedback information

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K992129 |

| Prescription Use<br>(Per 21 CFR 801.109) | X | OR | Over-the-Counter Use | |
|------------------------------------------|---|----|----------------------|--|
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