A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR

K980824 · A&D Engineering, Inc. · DXN · Mar 19, 1998 · Cardiovascular

Device Facts

• Record ID: K980824
• Device Name: A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR
• Applicant: A&D Engineering, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The UB-322 is designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate. The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. UB-322 is using oscillometric method to conduct the measurement. It is not designed for ambulatory use. The wrist circumference range shall be within 5.3 inches to 7.7 inches.

Device Story

The UB-322 is a watch-style, wrist-worn digital blood pressure monitor for home use by adults. It utilizes the oscillometric method to measure systolic and diastolic blood pressure and pulse rate. The device is operated by the patient; it is not intended for ambulatory monitoring. The user places the device on the wrist (5.3 to 7.7-inch circumference) to initiate measurement. The device processes pressure oscillations to calculate blood pressure and pulse values, which are displayed to the user. These readings assist patients in tracking their cardiovascular metrics at home.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Watch-style wrist digital blood pressure monitor; oscillometric measurement principle; battery-powered; wrist cuff form factor; intended for home use.

Indications for Use

Indicated for home use by adults 18+ years to monitor systolic/diastolic blood pressure and pulse rate. Contraindicated for patients with common arrhythmias (e.g., atrial/ventricular premature beats, atrial fibrillation). Not for ambulatory use. Wrist circumference must be 5.3 to 7.7 inches.

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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MAR 1 9 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

A&D Engineering, Inc. c/o Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298

K980824 Re : A&D UB-322 Watch Style Wrist Digital Blood Pressure Monitor Regulatory Class: II (Two) Product Code: DPW Dated: March 3, 1998 Received: March 4, 1998

Dear Mr. Mosenkis:

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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 Register. 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. Robert Mosenkis

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" (21 CFR 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/dsmamain.html."

Sincerely yours,

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

## Device Name: UB-322 Watch Style Wrist Digital Blood Pressure Monitor

## Indications for Use:

The UB-322 is designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate. The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. UB-322 is using oscillometric method to conduct the measurement. It is not designed for ambulatory use. The wrist circumference range shall be within 5.3 inches to 7.7 inches.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------------------------------|---------|
| (Division Sign-Off) Division of Cardiovascular Respiratory, and Neurological Devices | |
| 510(k) Number | K980824 |

Prescription Use __________ or Over-The-Counter Use X

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