E-READER

K970436 · Natural Herbal Products, Inc. · GZO · Aug 15, 1997 · Neurology

Device Facts

• Record ID: K970436
• Device Name: E-READER
• Applicant: Natural Herbal Products, Inc.
• Product Code: GZO · Neurology
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1540
• Device Class: Class 2

Intended Use

Galvanic Skin Resistance Measurement

Device Story

Device measures galvanic skin resistance; provides physiological data for clinical monitoring. Used in clinical settings by healthcare professionals. Output assists in patient assessment and clinical decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

Galvanic skin resistance measurement sensor; electronic circuitry for signal acquisition; standalone device.

Indications for Use

Indicated for the measurement of galvanic skin resistance in patients requiring physiological monitoring.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

AUG 15

Mr. John Riva-Cambrin
President of Operations
Natural Herbal Products, Inc.
10534 124 Street, Suite 206
Edmonton, Alberta T5N 1S1
CANADA

Re: K970436
Trade Name: E-Reader
Regulatory Class: II
Product Code: 84GZO
Dated: May 28, 1997
Received: June 4, 1997

Dear Mr. Riva-Cambrin:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. John Riva-Cambrin

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,

Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INDICATIONS FOR USE

Galvanic Skin Resistance Measurement

Prescription Use ☑
(Per 21 CFR 801.109)

Thomas J. Callahan
(Division Sign Off)
Division of — Respiratory,
and Neurological Devices
510(k) Number K970436

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