FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312

K012054 · Sein Electronics Co., Ltd. · DXN · Aug 8, 2001 · Cardiovascular

Device Facts

• Record ID: K012054
• Device Name: FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
• Applicant: Sein Electronics Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 8, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

To measure of systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.

Device Story

Full Auto Wrist Digital Blood Pressure Monitor (SE-312) is a non-invasive device for measuring blood pressure and pulse rate. It utilizes an oscillometric method via a wrist cuff. The device is intended for adult use. It automatically detects pressure oscillations to calculate systolic and diastolic blood pressure and pulse rate, displaying results for the user. It is designed for over-the-counter use, allowing patients to monitor their own blood pressure in a home or clinical setting. The output provides immediate physiological data to assist in tracking cardiovascular health.

Clinical Evidence

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

Technological Characteristics

Wrist-worn digital blood pressure monitor; oscillometric measurement principle; electronic sensor-based; battery-powered; standalone unit with integrated display.

Indications for Use

Indicated for the measurement of systolic and diastolic blood pressure and pulse rates in adult patients using a wrist cuff and 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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2001

Sein Electronics Co., Ltd. c/o Ms. Molly Bettger Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas. WA 98607-8542

Re: K012054

Trade Name: Full Auto Wrist Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulatory Class: Class II (two) Product Code: DXN Dated: July 27, 2001 Received: July 27, 2001

Dear Ms. Bettger:

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 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). 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 (Premarket Approval), 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 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 - Ms. Molly Bettger

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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (1) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = 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 Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Kark Till

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

Enclosure

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## Indications for Use Statement

| 510(k) Number (if known): | KO12054 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Full Auto Wrist Digital Blood Pressure Monitor, SE-312 |
| Indications for Use: | To measure of systolic and diastolic blood pressure and<br>pulse rates of adults using wrist cuff and oscillometric<br>method. |

(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dan Till
Division of Cardiovascular & Respiratory Devices
510(k) Number K012054

Prescription Use _ (Per 21 CFR 801.109) or

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)

the state of the state of the status and the subject of