ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46

K993542 · Rossmax International , Ltd. · DXN · Dec 29, 1999 · Cardiovascular

Device Facts

• Record ID: K993542
• Device Name: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46
• Applicant: Rossmax International , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 29, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.

Device Story

Device is an automatic wristwatch blood pressure monitor; utilizes oscillometric method to measure systolic/diastolic blood pressure and heart rate; intended for patient self-use at home or in clinical settings; device wraps around wrist; provides digital readout of blood pressure and pulse; assists users in monitoring cardiovascular health; healthcare providers use output to assess hypertension or track blood pressure trends.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison.

Technological Characteristics

Wrist-worn oscillometric blood pressure monitor; electronic sensor; digital display; battery-powered; non-invasive measurement.

Indications for Use

Indicated for adults over 18 years with wrist circumference 5.3-7.7 inches for measurement of systolic/diastolic blood pressure and heart rate.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## DEC 2 9 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Yeh Managing Director Rossmax Intl. LTD. 5F. NO.6, Alley 20 Lane 106 Section 3, Nan Kang Road Taipei, Taiwan

Re: K993542 Rossmax Automax WristWatch Blood Pressure Monitor Regulatory Class: II Product Code: DXN Dated: December 13, 1999 Received: December 16, 1999

Dear Mr. Yeh:

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 requirements, 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 regulation may result in regulatory action. In addition, the Food and Drug 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 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. Michael Yeh

This letter will allow you to continue 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]. 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 L. Bette R. Lempirle

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

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ATTACHMENT 1

K 993542

Intl. LTD Kossmax

## Indications for Use Statement

Rossmax Automatic Wristwatch Blood Pressure Monitor, model Device Names: V46

Indications For Use:

To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bura L. Kemperle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K993542 510(k) Number

Prescription Use_

or

Over-the-counter use