BLOOD-PRESSURE METER, BPW120

K050083 · Idt Technology Limited · DXN · Apr 8, 2005 · Cardiovascular

Device Facts

• Record ID: K050083
• Device Name: BLOOD-PRESSURE METER, BPW120
• Applicant: Idt Technology Limited
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel. The intended for use of this device is for age 15 and above.

Device Story

The BPW120 is an automated non-invasive blood pressure monitor. It utilizes the oscillometric method to detect arterial pressure oscillations. The device processes these signals to calculate systolic, diastolic, and mean blood pressure, as well as heart rate. Results are displayed on an integrated LCD panel. Designed for use by individuals aged 15 and older, it is intended for over-the-counter use. The device provides immediate numerical feedback to the user, facilitating self-monitoring of cardiovascular metrics.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Non-invasive blood pressure measurement system; oscillometric sensing principle; LCD display; battery-powered; standalone unit.

Indications for Use

Indicated for individuals aged 15 and older for the automatic measurement of systolic, diastolic, mean blood pressure, and heart rate using the oscillometric method.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

APR 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IDT Technology Limited c/o Dr. Lily Li Biomedical Specialist Block C, 9/F., Kaiser Estate, Phase 1 41 Man Yue Street Hunghom, Hong Kong CHINA 300193

Re: K050083

Trade Name: BPW120 Blood Pressure Meter Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: March 29, 2005 Received: March 31, 2005

Dear Dr. Li:

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 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) 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, 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

{1}------------------------------------------------

Page 2 - Dr. Lily Li

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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-frée number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Brimmer for

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

Enclosure

{2}------------------------------------------------

## Indications for Use

K050083 510(k) Number (if known):

Device Name: Blood-pressure meter, Model BPW120

Indications For Use:

By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.

The intended for use of this device is for age 15 and above.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Image /page/2/Picture/9 description: The image shows a handwritten 'X' mark next to a horizontal line. The word 'Use' is partially visible to the left of the line. The 'X' mark is formed by two diagonal lines that intersect each other.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummina

Sirin-Off ardiovasc VICES 511

Page 1 of