ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000

K964153 · Rossmax International , Ltd. · DXN · Jun 11, 1998 · Cardiovascular

Device Facts

• Record ID: K964153
• Device Name: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000
• Applicant: Rossmax International , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 11, 1998
• Decision: SESE
• Submission Type: Traditional
• 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 of 5.3 to 7.7 inches.

Device Story

Rossmax RM 4000 is an automatic wristwatch blood pressure monitor; utilizes oscillometric method to measure systolic/diastolic blood pressure and heart rate. Device worn on wrist; intended for over-the-counter use by adult patients. Input consists of pressure oscillations detected during cuff deflation; internal processing calculates blood pressure and pulse rate values. Output displayed on integrated screen for patient review. Facilitates home monitoring of cardiovascular metrics; aids in tracking blood pressure trends.

Clinical Evidence

No clinical data provided; substantial equivalence 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. Battery-powered. Standalone operation.

Indications for Use

Indicated for adults over 18 years with wrist circumference 5.3-7.7 inches for non-invasive 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)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 11 1998

Mr. Michael Yeh
President
Rossmax International, Ltd.
2F., No.8, Alley 20 Lane 106
Section 3, Nan Kang Road
Taipei, Taiwan

Re: K964153
Rossmax - Automatic Wristwatch Blood Pressure Monitor - RM 4000
Regulatory Class: II (Two)
Product Code: DXN
Dated: May 12, 1998
Received: May 14, 1998

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 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 Act. The general controls provisions of the Act include 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 Federal Register. Please note: this response to your premarket 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.

{1}

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" (21 CFR 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/dsmamain.html."

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{2}

Page 1 of 1

# INDICATIONS FOR USE

510(k) Number: K964153

Device Name: Rossmax RM 4000 Wristwatch Blood Pressure Monitor

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 of 5.3 to 7.7 inches.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K964153

Prescription Use ☐
(Per CFR 801.109)

or

Over-the-counter use ☑