CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026

K073445 · Taidoc Technology Corporation · DXN · Apr 2, 2008 · Cardiovascular

Device Facts

• Record ID: K073445
• Device Name: CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026
• Applicant: Taidoc Technology Corporation
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Clever TD-3026 Digital Wrist Blood Pressure Monitor is intended to be used to measure non-invasively the systolic and diastolic blood pressure 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 5.25" - 7.75".

Device Story

Clever TD-3026 is a digital wrist blood pressure monitor for home use. Device utilizes an inflatable cuff wrapped around the wrist to measure systolic/diastolic blood pressure and pulse rate via oscillometric technique. User operates device independently; results displayed on integrated screen. Output provides immediate feedback on hemodynamic status, allowing patients to monitor blood pressure trends at home. Device intended for adult population (18+).

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison to predicate technology.

Technological Characteristics

Non-invasive oscillometric blood pressure monitor. Wrist-worn form factor with inflatable cuff (5.25"-7.75"). Battery-powered. Digital display. Software-based signal processing for pressure oscillation analysis.

Indications for Use

Indicated for non-invasive measurement of systolic/diastolic blood pressure and pulse rate in adults over 18 years of age for home use. Cuff size limited to 5.25"-7.75" 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2008

TaiDoc Technology Corporation c/o Ms. Erica Li 6F, No. 127 Wugong 2nd Rd. Wugu Township Taipei County 24888 Taiwan

Re: K073445

Trade/Device Name: Clever TD-3026 Digital Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: March 4, 2008 Received: March 5, 2008

Dear Ms. 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.

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Page 2 - Ms. Erica Li

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/industry/support/index.html.

Sincerely yours,

Blymmiman for

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

K073445

## Indications for Use

510(k) Number:

Clever TD-3026 Digital Wrist Blood Pressure Monitor Device Name:

Indications for Use:

Clever TD-3026 Digital Wrist Blood Pressure Monitor is intended to be used to measure non-invasively the systolic and diastolic blood pressure 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 5.25" - 7.75".

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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