EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M

K021239 · Eikon Healthcare Device Corp. · DXN · Nov 8, 2002 · Cardiovascular

Device Facts

• Record ID: K021239
• Device Name: EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M
• Applicant: Eikon Healthcare Device Corp.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The EIKON automatic digital blood pressure monitor, Model HD-400M, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 16, 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

Eikon HD-400M is an automatic digital blood pressure monitor; uses oscillometric method via inflatable wrist cuff. Input: pressure oscillations during cuff deflation. Output: systolic/diastolic blood pressure and pulse rate on digital display. Intended for home use by adult patients (>16 years). Device provides automated readings to assist users in monitoring blood pressure; facilitates self-management of health. No physician intervention required for operation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-invasive oscillometric blood pressure measurement system. Wrist-worn inflatable cuff (5.3"-8.5" circumference). Digital display. Battery-powered. Software-controlled automated inflation/deflation and signal processing.

Indications for Use

Indicated for non-invasive measurement of systolic/diastolic blood pressure and pulse rate in adults over age 16. Intended for home use. Cuff size limited to 5.3"-8.5" wrist circumference.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Eikon Healthcare Device Corp. c/o Dr. Jen, Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-CHU City Taiwan, ROC

Re: K021239

Trade Name: Eikon Automatic Digital Blood Pressure Monitor, Model HD-400M Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 5, 2002 Received: August 12, 2002

Dear Dr. Ke-Min:

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.

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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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dia Mumbulu for

Benson D. Zakeu, M.D.

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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CIKON Healthcare Device Corp. TOMSON IND. Park, 5F-4, No. 14, Lane 609, Sec. 5, Chung-Shing Road, San-Chung City, Taipei Hsien, 241, Taiwan, ROC Telephone: [phone] Fax: [phone] Email: [e-mail]

Applicant: EIKON Healthcare Device Corp. Ko21239 510(k) Number ( if known): __ TBA Device Name: EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR HD-400M

0 Indications for use:

The EIKON automatic digital blood pressure monitor, Model HD-400M, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 16, 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".

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Concurrence of CDRH, office of Device Evaluation (ODE )

Number K021239

Dra Jluulee

Prescription Use

OR

Over-The-Counter-Use X

( Per 21 CFR 801.109 )

( Optional Format 1-2-96 )