ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS

K013539 · Rossmax International , Ltd. · DXN · Jan 17, 2002 · Cardiovascular

Device Facts

• Record ID: K013539
• Device Name: ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F 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 models 100f, 200f, and 300f are non-invasive blood pressure monitors designed for home use by adult consumers. Devices measure systolic and diastolic blood pressure and pulse rate. Operation involves standard oscillometric measurement techniques. Users apply the cuff to the arm; device automatically inflates, detects pressure oscillations, and calculates blood pressure and pulse values. Results are displayed on an integrated screen for user review. Provides patients with a convenient method for monitoring blood pressure trends at home, facilitating self-management and communication with healthcare providers.

Clinical Evidence

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

Technological Characteristics

Non-invasive oscillometric blood pressure monitor; measures systolic/diastolic pressure and pulse rate; intended for home use; digital display; electronic operation.

Indications for Use

Indicated for adult consumers in a home environment for 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: K013539

Trade Name: Rossmax MediPro Model 100f, 200f, 300f 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 14, 2001 Received: October 24, 2001

Dear Mr. Yeh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sualed in the encreases of 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 may or subject to been 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 forth in the quality systems (QS) regulation (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,

Dalla Teh

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

Enclosure

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## Appendix l INDICATIONS FOR USE STATEMENT

510(K) Number:

. . . .

| Device Name: | Rossmax MediPro model 100f, 200f, and 300f Blood<br>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)

or

Prescription Use______________________________________________________________________________________________________________________________________________________________

l Over-the-Counter Use

Dale Hill

Division of Cardiovascular & Respiratory Devices
510(k) Number K013559