ZEWA MFM-007 BLOOD PRESSURE MONITOR

K041491 · Zewa, Inc. · DXN · Sep 20, 2004 · Cardiovascular

Device Facts

• Record ID: K041491
• Device Name: ZEWA MFM-007 BLOOD PRESSURE MONITOR
• Applicant: Zewa, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Zewa® MFM-007 Blood Pressure Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped around the upper arm.

Device Story

The Zewa MFM-007 is a non-invasive blood pressure monitor for adult use. It utilizes an inflatable cuff wrapped around the upper arm to capture physiological signals. The device incorporates a semiconductor sensor, an internal air pump, and a battery power source. It processes pressure oscillations to calculate systolic and diastolic blood pressure and pulse rate, displaying results on an integrated LCD screen. Operated by the user via physical keys, it is intended for home or clinical use. The output provides immediate blood pressure and heart rate readings to assist in monitoring cardiovascular status.

Clinical Evidence

Bench testing only. The device was tested for compliance with technical specifications, including general performance under environmental conditions, static electrical discharge, irradiated electromagnetic fields, and radio screening.

Technological Characteristics

Non-invasive oscillometric blood pressure monitor. Components: inflatable upper arm cuff, semiconductor pressure sensor, internal air pump, LCD display, battery power source, and user interface keys. Operates via electronic sensing of pressure oscillations. No specific material standards or software architecture details provided.

Indications for Use

Indicated for adult patients with moderately active to inactive lifestyles for non-invasive measurement of systolic/diastolic blood pressure and pulse rate via upper arm cuff.

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.

Predicate Devices

• Meditec MD-800 Noninvasive Blood Pressure Measurement System (K992328)

Submission Summary (Full Text)

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K041491

# 510(K) SUMMARY SECTION 16

# 1. DATE PREPARED

June 2, 2004

## 2. SPONSOR INFORMATION

Zewa Inc. Mr. Thomas Zeindler 3537 N.W. 115th Avenue Miami, Florida 33178

[phone] (telephone) [phone] (facsimile)

# 3. DEVICE NAME

Proprietary Name: Zewa® MFM-007 Blood Pressure Monitor Common/Usual Name: MFM-007 Blood Pressure Monitor Classification Name: System, Measurement, Blood Pressure, Non Invasive

#### 4. DEVICE DESCRIPTION AND INTENDED USE

The Zewa® MFM-007 Blood Pressure Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflated cuff which is wrapped around the upper arm.

# PREDICATE DEVICE న్.

It is substantially equivalent to the Meditec MD-800 Noninvasive Blood Pressure Measurement System cleared by FDA on July 21, 1999, under 510(k) K992328.

### TECHNOLOGICAL CHARACTERISTICS 6.

The Zewa® MFM-007 Blood Pressure Monitor measures the systolic and

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diastolic blood pressure, and pulse rate (heart rate) by use of an inflatable cuff that is wrapped around the upper arm, a LCD display, a semiconductor sensor, and internal air pump, a battery power source and keys for operation.

# DEVICE TESTING 7.

The Zewa® MFM-007 Blood Pressure Monitor was tested for compliance with numerous technical specifications, including general performance under certain environmental conditions, influences of static electrical discharges, influences of irradiated electromagnetic field, and radio screening.

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Public Health Service

Image /page/2/Picture/2 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border. Inside the circle is a stylized image of an eagle with three stripes across its body. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2004

Zewa, Inc. c/o Mr. Thomas Zeindler Vice President 3537 N.W. 115th Avenue Miami, FL 33178

Re: K041491

. Trade/Device Name: Zewa MFM-007 Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: II (two) Product Code: DXN Dated: June 2, 2004 Received: June 4, 2004

Dear Mr. Zeindler:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bectoril 310(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure) to regars nement date of the Medical Device Americal Ford. Days commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food. Drug. devices that have been reclassined in asses approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require subject to the general controls provisions of the Act. The 1 ou may, dicierore, market the device, poolee requirements for annual registration, listing of general controls provisions of the flev labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see abort) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations on may be subject to such additional consolors, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous cements concerning your device in the Federal Register.

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Page 2 – Mr. Thomas Zeindler

Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that FDA s issuation of a buobained with other requirements of the Act
that FDA has made a determination that your device complies with other requirements o that FDA has made a determination that your are for a level Federal agencies. You must or any Federal Statutes and regulations damading, but not limited to: registration and listing (21 l comply with an the Act 3 requirements, mercess comments on the practice requirements as set CFK Part 807), labeling (21 CFR Part 800), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctors of 1 vice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your be I his letter will anow you to begin maileting your antial equivalence of your device to a legally premitset notification. The PDA miang of basification 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 advice for your de 110 - 110 - 4648. Also, please note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note Colliact the Office of Compunation at (50 m ) (21CFR Part 807.97). You may obtain " Misorationing by reletence to premanton notifications in the Act from the Division of Small other general informational 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,

Dffimmuma for
Brain 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): K041491

Device Name: Zewa MFM-007 Blood Pressure Monitor

Indications For Use:

The Zewa MFM-007 Blood Pressure Monitor is intended for use by adults with moderately active to inactive lifestyles for measuring the systolic and diastolic blood moderately active to machie in ste) by using an inflated cuff which is wrapped around the upper arm.

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)

Bhimma for
(Division Sign Off)

Division of Cardiovascular Devices

510(k) Number k041491

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