HEALTH CHECK KIOSK

K063008 · Xperex Corporation · DXN · Jun 7, 2007 · Cardiovascular

Device Facts

• Record ID: K063008
• Device Name: HEALTH CHECK KIOSK
• Applicant: Xperex Corporation
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Health Check Kiosk is intended to be a multi-functional unit that provides tests for the general public to measure personal health parameters such as weight, body fat, blood pressure and pulse rate in public places and/or corporate environments.

Device Story

Kiosk located in public/non-medical settings (gyms, offices, retail); operated by general public for self-measurement of health parameters. Inputs: weight, body fat, blood pressure, pulse rate via integrated measurement devices. Device functions as a multi-functional collection unit; provides information only; non-diagnostic. Output: display of measured parameters to user. Benefits: convenient access to health data for personal monitoring and physician consultation.

Clinical Evidence

No clinical data. Bench testing only; device validated in conjunction with associated measurement modules.

Technological Characteristics

Multi-functional kiosk housing integrated measurement modules for weight, body fat, blood pressure, and pulse rate. Operates as a standalone unit in public environments. Technology is based on standard non-invasive measurement sensors consistent with predicate devices.

Indications for Use

Indicated for use by the general public to measure personal health parameters (weight, body fat, blood pressure, pulse rate). Not for diagnostic use; provides data for user consultation with personal physicians.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Lifeclinic International (K040562)
• Advanced Monitoring Caregiving (K051544)
• Remote Nurse (K041308)

Submission Summary (Full Text)

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Xperex Inc .. 510(k) Submission Health Check Kiosk 510(k) Summary September 22, 2006

JUN - 7 2007

## (1) Submitter Information

Name: Xperex Inc.

Address:

384 Oyster Point Blvd South San Francisco, CA 94080

Telephone Number: 650-266-2013

Contact Person:

Dr. George Myers Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

Date Prepared: September 22, 2006

(2) Name of Device

Trade Name: Health Check Kiosk Common Name: Kiosk for Measurement of Health Parameters Classification name: System, measurement, blood-pressure, non-invasive

(3) Equivalent legally-marketed devices.

1. Lifeclinic Inernational, K040562

2. Advanced Monitoring Caregiving, K051544

3. Remote Nurse, K041308

The Health Check Kiosk is a kiosk that is erected in public spaces, and provides a location where the general ~ublic can measure various health parameters. The Health Check kiosks are intended only to provide .formation, and are not for diagnostic use. No charge is made for use of the kiosk, but advertising may be

⁽⁴⁾ Description

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Xperex Health Check Kiosk

ssted inside of it. It is planned to locate the kiosk in non-medical settings such as gyms, corporate offices and retail stores.

(5) Intended Use

The Health Check Kiosk is intended to be a multi-functional unit that provides tests for the general public to measure personal health parameters such as weight, body fat, blood pressure and pulse rate in public places and/or corporate environments.

(6) Performance Data

(a) Non-clinical tests

Health Check Kiosk has been extensively validated by itself and in conjunction with the associated measurement devices.

(b) Clinical tests

Clinical tests are not necessary, since the Health Check Kiosk uses the same technology as the predicate devices.

. ) Conclusions

The Health Check Kiosk is equivalent in safety and efficacy to the legally-marketed predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2007

Xperex Corporation c/o Medsys Inc. George Myers 377 Route 17 S Hasbrouck Heights, NJ 07604

Re: K063008

Trade/Device Name: Health Check Kiosk Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 18, 2007 Received: May 21, 2007

Dear Mr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your your 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 for ass sured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to commerco pror of riay 2011-12-11 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). and Costhere Frev (110) for the device, subject to the general controls provisions of the Act. The r ou may, cherefore, mainer of the Act include requirements for annual registration, listing of general controls pro reserving 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 If your device is clussined (600 as 10) als. Existing major regulations affecting your device can inay be subject to subli 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 r lease oc acrised that I Dr. interest that your device complies with other requirements of the Act

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## Page 2 -- Mr. George Myers

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. 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), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

B/himmer for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Xperex Health Check Kiosk

Page 4-1

## Indications for Use

510(k) Number (if known): Kod 3008

Health Check Kiosk Device Name: and the country of the country of the country of the county of the county of the county of the county of the county of the county of the county of the county of the county of

Indications for Use:

The Health Check Kiosk is indicated for use by the general public so that a user can measure his/her own health parameters using devices cleared for use by the public. It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumima

Division of Cardiovascular Devices 510(k) Number_