WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK

K991545 · Industrielle Entwicklung Medizintechnik Und Vertri · DXQ · Jan 19, 2000 · Cardiovascular

Device Facts

• Record ID: K991545
• Device Name: WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK
• Applicant: Industrielle Entwicklung Medizintechnik Und Vertri
• Product Code: DXQ · Cardiovascular
• Decision Date: Jan 19, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended Use

The KLOCK Blood Pressure Monitor is to be used by adults as a Home Health Care device to monitor Blood Pressure (systolic and diastolic) and the Pulse rate at home. The Blood Pressure Measurement is obtained by the use of the oscillometric method, meaning that the monitor detects the blood's movement through the artery in the wrist and converts the movements into digital readings. The KLOCK is not intended to be used by people who have circulatory problems, such as arrhythmia, or if pregnant.

Device Story

Watch-style wrist-worn digital blood pressure monitor; utilizes oscillometric method to detect arterial blood movement in wrist; converts detected oscillations into digital systolic/diastolic blood pressure and pulse rate readings; intended for adult home self-use; provides immediate digital display of measurements to user; assists in routine health monitoring; device operation requires no specialized medical training.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Wrist-worn digital monitor; oscillometric sensing principle; battery-powered; digital display; standalone operation.

Indications for Use

Indicated for adult use in home settings to monitor systolic/diastolic blood pressure and pulse rate. Contraindicated for pregnant individuals and those with circulatory conditions, including arrhythmia.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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## JAN 1 9 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Guenter Ginsberg President Media Trade Corporation Industrielle Entwicklung Medizinttechnik 11641 Red Hibiscus Drive Bonita Springs, FL 34135

Re: K991545 Watch Style Wrist Digital Blood Pressure Monitor Regulatory Class: II Product Code: DXQ Dated: October 27, 1999 Received: November 1, 1999

Dear Mr. Ginsberg:

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 legally marketed predicate 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 general controls provisions of the Act include the Act. 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 reguirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Druq Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket Register. notification submission does not affect any obliqation 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.

This letter will allow you to continue marketing your device as described in your 510(k) premarket notification. The FDA finding

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## Page 2 - Mr. Guenter Ginsberg

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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

for/Bora R. Lemperle

Celia M. Witten, Ph.D. Acting Director Division of Cardiovascular Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indication for Use Statement

510(k) Number: K991545 Device Name: Watch Style Wrist Digital Blood Pressure Monitor

The KLOCK Blood Pressure Monitor is to be used by adults as a Home Health Care device to monitor Blood Pressure (systolic and diastolic) and the Pulse rate at home. The Blood Pressure Measurement is obtained by the use of the oscillometric method, meaning that the monitor detects the blood's movement through the artery in the wrist and converts the movements into digital readings. The KLOCK is not intended to be used by people who have circulatory problems, such as arrhythmia, or if pregnant.

Segre G. Kemperle

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(Division Sign Off)

Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurologic . Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

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