DAIWA MODEL 180

K983616 · Daiwa Products, Inc. · DXN · Oct 15, 1999 · Cardiovascular

Device Facts

• Record ID: K983616
• Device Name: DAIWA MODEL 180
• Applicant: Daiwa Products, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitor is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The device also measures the heart rate. The device is for adult use only and measures wrist circumferences from 5 1/4" to 7 3/4". The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation

Device Story

Daiwa Model 180 is an automatic inflation wrist digital blood pressure monitor. Device uses oscillometric method to detect pressure signals; calculates systolic/diastolic blood pressure and heart rate. Intended for adult home use; patient operates device by securing cuff to wrist. Output displayed on digital screen for user monitoring. Provides non-invasive hemodynamic data to assist in blood pressure management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Wrist-worn digital blood pressure monitor; utilizes oscillometric sensing principle; battery-powered; digital display; non-invasive measurement.

Indications for Use

Indicated for adult patients with wrist circumferences 5 1/4" to 7 3/4" for non-invasive measurement of systolic/diastolic blood pressure and heart rate. Contraindicated for patients with common arrhythmias, including atrial or ventricular premature beats or atrial fibrillation.

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

# OCT 1 5 1999

DAIWA PRODUCTS, INC. c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114

Re: K983616 DAIWA MODEL 180 Regulatory Class: II (TWO) Product Code: 74 DXN Dated: July 27, 1999 : Received: July 28, 1999

Dear Mr. Smith:

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 leqally 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). 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 Reqister. 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.

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Page 2 - Mr. E.J. Smith

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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

Enclosure

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#### x 98 3616 510(k) Number (if known):

Device Name: Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitors

Classification Panel:

### Indications for Use:

The Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitor is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The device also measures the heart rate. The device is for adult use only and measures wrist circumferences from 5 1/4" to 7 3/4". The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation

Bute Cooperle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 11983616 510(k) Number_

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

or

Over-the-Counter Use ﺳﺴﺎ