ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100

K992387 · Rossmax International , Ltd. · DPW · Aug 3, 1999 · Cardiovascular

Device Facts

• Record ID: K992387
• Device Name: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100
• Applicant: Rossmax International , Ltd.
• Product Code: DPW · Cardiovascular
• Decision Date: Aug 3, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2100
• 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

ROSSMAX Automatic Wristwatch Blood Pressure Monitor (Model RM-4100) is a non-invasive, oscillometric device for measuring blood pressure and heart rate at the wrist. Designed for over-the-counter use by adults over 18 years. Device uses an inflatable cuff to detect arterial pressure oscillations; internal processing calculates systolic and diastolic values and heart rate. Results are displayed on an integrated screen for user review. Intended for home monitoring to assist in tracking cardiovascular health metrics.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Wrist-worn oscillometric blood pressure monitor. Measures systolic/diastolic pressure and heart rate. Designed for wrist circumferences 5.3 to 7.7 inches. Operates via automated inflation/deflation cycle.

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 via oscillometric method.

Regulatory Classification

Identification

A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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## AUG -3 1999

Mr. Michael Yeh Managing Director ROSSMAX International Ltd. 2F. No. 10, Alley 20 Lane 106 Section 3, Nan Kang Road TAIPEI , CHINA (TAIWAN)

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re : K992387 ROSSMAX Automatic Wristwatch Blood Pressure Monitor, Model RM-4100 Requlatory Class: II (TWO) Product Code: DPW Dated: July 16, 1999 Received: July 19, 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, Druq, 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS 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 Please note: this response to your premarket Federal 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 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Call han, 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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## ATTACHMENT 1

## Indications for Use Statement

ROSSMAX Automatic Wristwatch Blood Pressure Monitor, Device Names: model RM-4100

To measure systolic and diastolic blood pressure and heart rate on Indications For Use: 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)

Prescription Use______________________________________________________________________________________________________________________________________________________________

or

**Over-the-counter use*****_***_