REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T

K041778 · Maxi-Aids, Inc. · DXN · Aug 31, 2004 · Cardiovascular

Device Facts

• Record ID: K041778
• Device Name: REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T
• Applicant: Maxi-Aids, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 31, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The device measures systolic and diastolic blood pressures and pulse rate. It uses the oscillometric method. It is indicated for use by adults (those 18 years of age and older) at home or in an outpatient setting.

Device Story

The Reizen Talking Blood Pressure Monitor (Model SF860T) is an oscillometric blood pressure measurement system. It is designed for use by adults in home or outpatient settings. The device measures systolic and diastolic blood pressure and pulse rate. It provides auditory output (talking feature) to assist users. The device is operated by the patient or user to monitor cardiovascular metrics, which can be used to track blood pressure trends and inform clinical decision-making regarding hypertension management.

Clinical Evidence

Bench testing only. The device demonstrated compliance with the ANSI/AAMI SP10 standard for noninvasive blood pressure measurement systems. No clinical trial data was required or provided.

Technological Characteristics

Oscillometric measurement principle. Device is a digital blood pressure monitor with auditory output. Complies with ANSI/AAMI SP10 standard. Quality system certified to ISO 9001/ISO 13485. Operates as a standalone unit.

Indications for Use

Indicated for adults (18+ years) for the measurement of systolic and diastolic blood pressure and pulse rate in home or outpatient settings.

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

• A&D Medical LifeSource Talking Digital Blood Pressure Monitor, Model UA-767 (K041778)

Submission Summary (Full Text)

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## AUG 3 1 2004

### 510(k) Summary

#### Sponsor Information:

Maxi-Aids 42 Executive Boulevard Farmingdale, NY 11735 Elliot Zaretsky Phone [phone] Facsimile [phone]

#### Date Prepared:

June 25, 2004

#### Device Name:

Proprietary Name: Reizen Talking Blood Pressure Monitor, Model SF860T

Common/Usual Name: Blood pressure monitor

Classification Name: Noninvasive blood pressure measurement system (per 21 C.F.R. § 870.1130)

#### Device Description, Intended Use, and Technological Characteristics:

The Reizen Talking Blood Pressure Monitor SF860T measures systolic and diastolic blood pressures and pulse rate. It uses the oscillometric method. It is indicated for use by adults (those 18 years of age and older) at home or in another outpatient setting. It has the same technological characteristics as the predicate device.

#### Predicate Device:

A&D Medical LifeSource Talking Digital Blood Pressure Monitor, Model UA-7671'

#### Performance Data:

The device has been certified as meeting the standards of the ISO 9001/ISO 13485 Quality System Standard. Further, it has been certified as complying with the applicable requirements of the European Union Medical Devices Directive (93/42/EEC). The device also passed testing to show conformance with the ANSVAAMI SP10 Standard.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2004

Maxi Aids, Inc. c/o Mr. Wayne H. Matelski 1050 Connecticut Avenue Washington, DC 20036-5339

Re: K041778

K041778
Trade Name: Reitzen Talking Blood Pressure Monitor, Model SF860T Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: June 28, 2004 Received: July 1, 2004

Dear Mr. Matelski :

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regary manated povice Amendments, or to commerce prof to May 28, 1976, the encenture with the provisions of the Federal Food. Drug, devices that have been icclassified in acceraalso was a proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica and Cosment Act (Act) that do not require approvinces in controls provisions of the Act. The Y ou may, merelore, market the devices, subject to annual registrator, listing of
general controls provisions of the Act include requirements for annual registration, disco. general controls provisions of the first 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 If your device is classifica (seculored in the exist is a major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entroller Controller of the 898. In addition, FDA may be found in the Oous overning your device in the Federal Register.

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Page 2 – Mr. Wayne H. Matelski

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA s issualice of a subcements with other requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA has made a determination alat your as recess by other Federal agencies. You must a or any Federal statules and regulations daminities or registration and listing (21)
comply with all the Act's requirements, including, but not limited to: registration resear comply with all the Act s requirements, more of any cannon of the requirements as setting the closetter CFK Part 807); labeling (21 CFR Part 800); government 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 am 1000 1 forin in the quality systems (QD) regalication (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctors 597 - vice as described in your Section 510(k)
This letter will allow you to begin marketing your device to logics to 100) I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally premarket nother 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), please if you desire specific advice for your ac 110 %. Also, please note the regulation entitled, contact the Office of Complians as (Set ) , (21CFR Part 807.97). You may obtain " Misoranding by reserved to premainter to be act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Goress http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R. Opler

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): K041778

Device Name: Reizen Talking Blood Pressure Monitor, Model SF860T

Indications For Use:

The device measures systolic and diastolic blood pressures and pulse rate. It uses the i he device measures systems and diacters brose prosessor age and older) at home or in an outpatient setting.

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)

Neil R.P. Ogden

| (Division Sign-Off)<br>Division of Cardiovascular Devices |
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510(k) Number,

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