LIFESOURCE MODELS UA-787, UA 787PC, UA-787T

K012013 · A&D Engineering, Inc. · DXN · Jul 13, 2001 · Cardiovascular

Device Facts

• Record ID: K012013
• Device Name: LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
• Applicant: A&D Engineering, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Measuring systolic and diastolic blood pressure and pulse rate in adult patients (18 years and older). The arm circumference should be between 5.1" and 17.7" (13 cm to 45 cm).

Device Story

LifeSource UA-787, UA-787PC, and UA-787T are digital blood pressure monitors; intended for adult patient use. Device measures systolic/diastolic blood pressure and pulse rate via oscillometric method. Operated by patient or clinician in home or clinical settings. Output displayed on device screen; UA-787PC model includes PC connectivity for data management. Provides objective blood pressure and pulse data to assist in monitoring cardiovascular health.

Clinical Evidence

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

Technological Characteristics

Digital oscillometric blood pressure monitor. Measures systolic/diastolic pressure and pulse rate. Designed for adult arm circumferences 13-45 cm. UA-787PC model features PC connectivity. Class II device (21 CFR 870.1130).

Indications for Use

Indicated for measuring systolic and diastolic blood pressure and pulse rate in adult patients (18+ years) with arm circumference 13-45 cm.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the shape of a bird or wing-like structure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Public Health Service

JUL 1 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

A & D Engineering, Inc. c/o Mr. Robert Mosenkis Citech 5200 Butler Pike Plymouth meeting, PA 19462

Re: K012013

Trade Name: LifeSource Models UA-787, UA-787PC, and UA-787T Regulation Number: 21 CFR 870.1130 Regulatory Class: Class II (two) Product Code: DXN Dated: June 27, 2001 Received: June 28, 2001

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 legally marketed predicate devices marketed in interstate commerce stired in the 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 provision, 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 ( reading 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

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## Page 2 - Mr. Robert Mosenkis

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.

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 nothloated. THE I Drive 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 11 you active specific and 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 mornation on your respect its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

toello

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

## Device Name: A&D Medical LifeSource UA-787, UA-787PC, & UA-787T Digital Blood Pressure Monitors

## Indications for Use:

Measuring systolic and diastolic blood pressure and pulse rate in adult patients (18 years Mcasuring Systeme and Charlerse office. The arm circumference should be between 5.1" and 17.7" (13 cm to 45 cm).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division of Cardiovascular & Respiratory Devices | |
|--------------------------------------------------|---------|
| 510(k) Number | K012013 |

Or

Prescription Use __________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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