ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS

K013583 · Rossmax International , Ltd. · DXN · Jan 17, 2002 · Cardiovascular

Device Facts

• Record ID: K013583
• Device Name: ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS
• Applicant: Rossmax International , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment.

Device Story

Rossmax MediPro/MediCare Models 10 and 60 are non-invasive blood pressure monitors designed for home use by adult consumers. The device utilizes an inflatable cuff to occlude blood flow and sensors to detect oscillometric signals. The internal system processes these signals to calculate systolic and diastolic blood pressure values and pulse rate. Results are displayed on an integrated screen for the user. The device provides automated monitoring, allowing patients to track their cardiovascular metrics independently without clinical supervision. The output assists users in monitoring their blood pressure status over time.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison to existing legally marketed devices.

Technological Characteristics

Non-invasive oscillometric blood pressure measurement system. Includes inflatable cuff, pressure sensor, and electronic processing unit. Designed for home use. Standalone device.

Indications for Use

Indicated for adult consumers in a home environment for the non-invasive measurement of systolic blood pressure, diastolic blood pressure, and pulse 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Mr. Michael Yeh Managing Director Rossmax International Ltd. 12F., No. 189, Kang Chien Road Taipei, 114 TAIWAN

Re: K013583

Trade Name: Rossmax MediPro Model 10 and 60, MediCare Model 10 and 60 Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 22, 2001 Received: October 30, 2001

Dear Mr. Yeh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Michael Yeh

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of A Fat 6077, lacemig (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

V. Walker Mitch

ram D. Zuckerman, M. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Appendix ﺍ INDICATIONS FOR USE STATEMENT

510(K) Number:

| Device Name: | Rossmax MediPro model 10 and 60, MediCare 10 and 60<br>Blood Pressure Monitor |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | Non-invasive blood pressure systems that measure systolic,<br>diastolic, and pulse rates for adult consumers in a home<br>environment. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

or

Over-the-Counter Use /

Division of Cardiovascular & Respiratory Devices
510(k) Number K013583