PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR.

K051862 · Ya Horng Electronic Co., Ltd. · DXN · Aug 23, 2005 · Cardiovascular

Device Facts

• Record ID: K051862
• Device Name: PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR.
• Applicant: Ya Horng Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The YA HORNG PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U, BP-410R; and Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5".

Device Story

Non-invasive wrist blood pressure monitors; measure systolic/diastolic pressure and pulse rate via inflatable cuff. Intended for home use by adult patients. Devices utilize oscillometric measurement technique. Models AK-4000TU, BP-410U, BP-420U feature USB connectivity for PC data transmission; models BP-410R, BP-420R feature RS232 connectivity. Output displayed to user; allows tracking of blood pressure trends. Benefits include convenient, self-administered monitoring of cardiovascular health.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance comparisons to the predicate device.

Technological Characteristics

Non-invasive oscillometric blood pressure measurement system. Wrist-worn inflatable cuff (5.3"-8.5"). Connectivity: USB (AK-4000TU, BP-410U, BP-420U) or RS232 (BP-410R, BP-420R) for PC data transfer. Digital display. Battery-powered.

Indications for Use

Indicated for non-invasive measurement of systolic/diastolic blood pressure and pulse rate in adults over age 18. For home use. Cuff circumference 5.3"-8.5".

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

• AMLUCK AUTOMATIC DIGITAL WRIST BLOOD PRESSURE MONITOR AK-3000 / AK-4000 (K012796)

Submission Summary (Full Text)

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K0518627

AUG 2 3 2005

**YAHORNG**
Ya Horng CO., LTD.

No. 35, Zsha Lun, Jon Zsha village, Antin Shiang, Tainan, Taiwan, ROC Tel: [phone] Fax: [phone] E-mail: [e-mail] http:// www.yahorng.com

## "510(k) Summary"

Submitter's Name: YA HORNG Electronic Co., Ltd.

Address: No. 35, Zaha Lun, Jon Zsha Village, Antin Shiang, 745, Taiwan, ROC

Telephone: [phone]

> FAX: [phone]

Contact Person: Dr. Jen, Ke-Min

Date Summary July 4, 2005 Prepared:

Proprietary Name: PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U, BP-410R ; Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R

- Common Name: BLOOD PRESSURE MONITOR
Classification Name: NON-INVASIVE BLOOD-PRESSURE MEASUREMENT SYSTEM

( per 21CFR section 870.1130)

- Device Class: Class II (performance standards)
- Specialty: CARDIOVASCULAR

Product code: DXN

AMLUCK AUTOMATIC DIGITAL WRIST BLOOD Legally Marketed PRESSURE MONITOR AK-3000 / AK-4000 ( Predicate ) Device : 510(k) No: K012796

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2005

Ya Horng Electronic CO., Ltd. c/o Dr. Jen, Ke-Min ROC Chinese-European Industrial Research Society No.58, Fu-Chiun St. Hsin-Chu City CHINA (TAIWAN) 300

Re: K051862

Trade Name: Amluck Ya Horng PC Compatible Blood Pressure Monitor, AK-4000TU, BP-410U,BP-410R; and, Automatic Digital Wrist Blood Pressure Monitor, BP-420U, BP-420R Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: July 4, 2005 Received: July 8, 2005

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interested commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federall Food, Drug and Cosmetic Act (Act) that do not require approval of a premarket approval application(PMA), 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Dr. Jen Ke-Min

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram Dl Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for Ya Horng CO., LTD. The logo is in black and white, with the words "YA HORNG" in large, bold letters. Below the large text is the company name "Ya Horng CO., LTD" in a smaller font. The logo is simple and easy to read.

No. 35, Zsha Lun, Jon Antin Shiang, Tainan, Taiwan, ROC Tel: [phone] Fax: [phone] http:// www.yahorng.com E-mail: [e-mail]

## Indications for Use

510(k) Number:

K051862

Device Name: YA HORNG ELECTRONIC CO., LTD. PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U, BP-410R : Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R

● Indications for use:

The YA HORNG PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U, BP-410R; and Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5".

. Note:

BP-410R , BP-420R : Data Transmission: Connection to PC using RS232 cable. AK-4000TU, BP-410U, BP-420U: Data Transmission: Connection to PC using USB cable

| Prescription Use | AND/OR | Over-The-Counter Use | √ |
|-----------------------------------------------------------------------------|---------|------------------------|---|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE<br>IF NEEDED) | | | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
| (Division Sign-Off)<br>Division of Cardiovascular Devices | | | |
| 510(k) Number | K051862 | | |