WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES

K041693 · Hangzhou Hua'An Medical & Health Instruments Co., · DXN · Dec 2, 2004 · Cardiovascular

Device Facts

• Record ID: K041693
• Device Name: WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
• Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The model MW-300 series wrist pressure monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.

Device Story

Wrist-worn digital sphygmomanometer; measures blood pressure and pulse rate noninvasively. Designed for home use by adults; operation initiated by individual or as part of provider-supervised hypertension management. Device utilizes oscillometric sensing technology to detect arterial pressure oscillations; processes signals to calculate systolic/diastolic pressure and pulse rate. Output displayed on integrated screen for user review; facilitates self-monitoring of cardiovascular health. Supports hypertension management by providing actionable data for clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance specifications for noninvasive blood pressure monitoring.

Technological Characteristics

Wrist-worn digital sphygmomanometer; oscillometric measurement principle; battery-powered; digital display; non-invasive cuff-based sensing; intended for home use.

Indications for Use

Indicated for noninvasive measurement of systolic/diastolic blood pressure and pulse rate in adults in home settings. Suitable for individual use or as part of provider-supervised hypertension management programs.

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

DEC - 2 2004

Hangzhou Hua'an Medical & Health Instruments Co., Ltd. c/o Mr. Ji Bo Manager Building 2, Baimiao Industrial Park Economic Development Zone Wuchang Hangzhou, Zheijiang 310023 CHINA

Re: K041693

Trade Name: Wrist Digital Blood Pressure Monitor (Digital Sphygmomanometer) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: October 20, 2004 Received: October 22, 2004

Dear Mr. Bo:

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 may or daysee 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. Ji Bo

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised mat 1 Dris issualles complies with other requirements of the Act that I Dri has made a devel regulations administered by other Federal agencies. You must of ally I coleral statutes and regulations and limited to: registration and listing (21 Comply with an the Act 3 requirements, 01); good manufacturing practice requirements as set CFN in the quality systems (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Section your device as described in your Section 510(k) I mis icher wif anow you to ough inding of substantial equivalence of your device to a legally premarket notification: "The PDF intems sification 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), please If you desire specific acries 101) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. INhisoranums of reference to promresponsibilities under the Act may be obtained from the Other general information on your respectional 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,

Bhimiman for

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

Enclosure

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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Wrist digital blood pressure monitor (Digital Sphygmomanometer), Device Name: Model MW-300 Series

Indications For Use:

The model MW-300 series wrist pressure monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.A.mmelar

510íki Number

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