LIFECLINIC, MODEL 2400

K040562 · Lifeclinic International, Inc. · DXN · Aug 31, 2004 · Cardiovascular

Device Facts

• Record ID: K040562
• Device Name: LIFECLINIC, MODEL 2400
• Applicant: Lifeclinic International, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 31, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Lifeclinic 2400 is intended to be used by the general public so that a user can measure his/her own blood pressure and pulse rate. It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians.

Device Story

Lifeclinic 2400 is an automated, non-invasive blood pressure and pulse rate monitor for public use in retail or clinical settings. Device features a fixed cuff; user inserts arm and initiates measurement via button press. System utilizes oscillometric method for pressure determination. Operation is guided by interactive screens and voice instructions. Device outputs blood pressure and pulse rate data to the user. Data is intended for informational purposes to facilitate consultation with a personal physician; device performs no diagnostic functions.

Clinical Evidence

Bench testing only. The device meets all required AAMI tests for non-invasive blood pressure measurement systems. No clinical tests were required.

Technological Characteristics

Fixed cuff assembly; oscillometric measurement principle; automated inflation/deflation; interactive screen and voice guidance interface. Meets AAMI standards for non-invasive blood pressure monitors.

Indications for Use

Indicated for the measurement of blood pressure and heart rate by members of the general public. Not for diagnostic use; provides data for user consultation with a physician.

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

• BP/Clinic (K850893)

Submission Summary (Full Text)

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# AUG 3 1 2004

K040562/Si
Page A 2 page 1 of 2

## HealthGuard International Inc. Special 510(k) Model 2400 Automatic Blood Pressure Measurement System 510(K) Summary

December 11, 2003

#### (1) Submitter Information

Name: HealthGuard International Inc..

Address: 255 North Washhington St. Rockville, MD 20850

Telephone Number: 301-279-7300

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703

Date Prepared: February 20, 2004

(2) Name of Device:

Trade Name: Lifeclinic 2400 Common Name: Automated Blood Pressure Monitor. Classification Name: System, measurement, blood pressure, non-invasive, systolic and/or diastolic, 74JOE, 870.1130

(3) Equivalent legally-marketed devices:

K850893, "BP/Clinic"

(4) Description

The Lifeclinic 2400 is an automated system for measuring blood pressure and pulse rate designed to be used by the general public in stores and other places. It is completely automatic, and measures blood pressure by the oscillometric method. The user is guided by a series of interactive screens and voice instructions.

(5) Intended Use

The Lifeclinic 2400 is intended to be used by the general public so that a user can measure his/her own blood pressure and pulse rate. It is not a diagnostic device, and only furnishes data so that users can consult their personal physicians.

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(6) Technological characteristics

The Lifeclinic 2400 consists of a fixed cuff into which the user inserts an arm. The cuff automatically inflates and then deflates after the user presses a button. The device measures blood pressure using the oscillometric method.

(b) Performance data

(1) Non-clinical tests

The unit meets all required AAMI tests for such devices.

(2) Clinical tests

Not required

(3) Conclusions

The Lifeclinic 2400 is equivalent in safety and efficacy to the legally marketed predicate device.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2004

Lifeclinic International, Inc. c/o Mr. George H. Myers Medsys, Inc. 377 Route 17 S. Hasbrouck Heights, NJ 07604

Re: K040562 Trade Name: Lifeclinic LC500 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 19, 2004 Received: August 20, 2004

Dear Mr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premained instantially equivalent (for the indications referenced above and nave determined the devices marketed in interstate for use stated in the encrosule) manetoo people the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Foders' Food. Drug commerce prior to May 28, 1776, the enaominen with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provision of the Unite devices that have been iccassified in accessaries with of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the A and Cosment Act (Act) that do not require approvide of the general controls provisions of the Act. The You may, therefore, market me devreet, boojer to the more
general controls provisions of the Act include requirements for annual registration, listing of the general controls provisions of the Field of the rise of the magainst 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 classified (see above) mo existing major regulations affecting your device can
may be subject to such additional controls. Existing major and condition ED may be subject to such adultional controlls. Extoung and on 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Peacharting your device in the Federal Register.

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Page 2 – Mr. George H. Myers

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substitive with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decemmanon that your about were Federal agencies. You must or any Federal statutes and regulations daministered of registration and listing (21
comply with all the Act's requirements, including, but not limited to: registration and l comply with an the Act s requirements, merces with the practice requirements as set CFR Part 807), labeling (21 CFR Part 820); good and frapplicable, the electronic forth in the quality systems (Q5) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1 product radiation control provisions (Decicens of Persons of Person Survice as described in Jour Section 5 10(k) I his letter will anow you to begin marketing your avoire of your device to a legally premarket nothication. The PDA miding of backanna virus, permits your device to proceed to the market.

If you desire specific advice for your device on our lated it (21 CFR Part 801), please
s the received in the same of the same of the recults to recults to recultive antitled If you desire specific advice for your do not on our and a more one one the regulation entitled, contact the Office of Comphalled at (501) 991 16 16 (1CFR Part 807.97). You may obtain "Misolanding by reference to premantevisibilities under the Act from the Division of Small other general information on your responsion.com and its toll-free number [phone] or Manufacturers, International and Gozess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R. Ogden

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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K040562

# Lifectinic 500 K040562 Added Information

Page 10

Page _________________________________________________________________________________________________________________________________________________________________________

K040562 510(k) Number (if known):__

Device Name: Lifeclinic LC500

Indications for Use:

The Lifeclinic LC500 is indicated for the measurement of blood pressure and heart rate by members of the general public. The device does not perform any diagnoses; it only provides pressure and rate data to the users, who are advised to consult a physician.

### Prescription Use (Pcr 21 CFR 810.109)

OR

Over-the-Counter Use

(Per 21 CFR 810.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

RX

(Division Sign-Off)
Cardiovascular Devices
C

510(k) Number. K040562