MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822

K043531 · K-Jump Health Co., Ltd. · DXN · Apr 21, 2005 · Cardiovascular

Device Facts

• Record ID: K043531
• Device Name: MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
• Applicant: K-Jump Health Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Arm BPM is intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use in adults.

Device Story

Device is an arm-based blood pressure monitor; utilizes inflatable cuff wrapped around upper arm; incorporates semiconductor sensor to detect pressure oscillations; internal air pump manages cuff inflation; LCD displays systolic, diastolic, and pulse rate measurements; intended for adult use; operated by user via integrated keys; powered by battery or AC/DC source; provides non-invasive cardiovascular monitoring for home or clinical settings.

Clinical Evidence

Bench testing only; compliance with EN60601-1 standards confirmed.

Technological Characteristics

Non-invasive blood pressure monitor; semiconductor sensor; inflatable cuff with Velcro; LCD display; internal air pump; battery or AC/DC power; complies with EN60601-1.

Indications for Use

Indicated for use in adults to measure systolic, diastolic, and pulse rate via an 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

• K-jump Health Co., Ltd. Arm Blood Pressure Monitor Models KP-6821, KP-6822

Submission Summary (Full Text)

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## ATTACHMENT 4

## APR 2 1 2005

## 510(k) Summary

K043531/

K-jump's Arm Blood Pressure Monitor, Models KP-6821A, KP-6822A series. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Daniel Tseng K-jump Health Co., Ltd No. 56 Wu Kung 500 Road Wu Ku Industrial Park Taipei Hsien, Taiwan Phone: [phone] Facsimile: [phone] Date Prepared: December 9, 2004

#### Name of Device and Name/Address of Sponsor

Arm Blood Pressure Monitor, Models KP-6821A and KP-6822A K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, Taiwan Phone: [phone] Facsimile: [phone] Contact person: Daniel Tsenq

| Common or Usual Name: | Blood Pressure Monitor |
|-----------------------|-----------------------------------------------------------|
| Classification Name: | System, Measurement, Blood Pressure, Non-invasive |
| Predicate Device: | K-jump Health Co., Ltd. Arm Blood Pressure Monitor Models |
| | KP-6821, KP-6822 |

#### Intended Use

The Arm BPM is intended to measure the systolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use in adults.

#### Technological Characteristics

The Arm BPM is designed to measure the systolic, and pulse rate (heart rate) of an individual. The device consists of an inflatable cuff that is wrapped around the upper arm and held in place with Velcro™, a LCD display, a semiconductor sensor, an internal air pump, a battery power or AC/DC power source, and keys for operation.

#### Performance Data

In addition to the conformity standards of the predicate device, this Arm BPM also complies with EN60601-1 (LVD test).

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Image /page/1/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2005

K-Jump Health Co., Ltd. c/o Mr. Daniel Tseng President and CEO No.56 Wu Kung 5th Road Wu Ku Industrial Park TaiPei Hsien TAIWAN

Re: K043531

Ko45531
Trade Name: Arm Blood Pressure Monitor, Models, KP-6821A and KP-6822A Regulation Number: 21 CFR 870.1130 Regulation Name: Blood Pressure Monitor Regulatory Class: Class II Product Code: DXN Dated: December 09, 2004 Received: December 21, 2004

Dear Mr. Tseng:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosule) to regists the Medical Device Amendments, or to conninered prof to May 20, 1978, the occordance with the provisions of the Federal Food, DNIg, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, manel of the Act include requirements for annual registration, listing of general controls provisions of arctice, 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 classified (500 above) ans. Existing major regulations affecting your device can Inay be subject to suen additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs acements concerning your device in the Federal Register.

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Page 2 – Mr. Daniel Tseng

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated or a bevice complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must or any Federal statutes and regariations and admited to: registration and listing (21 Comply with an the 70c s requirements, n.i. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Device as described in your Section 510(k) I ms letter will anow you to begin manicaling of substantial equivalence of your device to a legally premarket notification. The PDA midning of backansal of the 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 as not the case note the regulation entitled, and Colliact the Orice of Complanes at (21CFR Part 807.97). You may obtain " Misbranding by relefence to premants. Louited in the Act from the Division of Small other general information on your responsible in the toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dmula R. Vochmer

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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## ATTACHMENT 2

# Indications for Use Statement

510(k) Number (if known): __ K04353)_

#### Device Name:

Arm Blood Pressure Monitor models KP-6821A, KP-6822A

## Indications for Use:

The Arm BPM is intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use in adults.

Prescription Use (Per 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFT 807 Subpart C) OR

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Muna R. Mc luner

Concurrence of CDRH, Office

**510(k) Number** < 043531