← Product Code [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN) · K091897 # BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019 (K091897) _Taidoc Technology Corporation · DXN · Aug 25, 2009 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K091897 ## Device Facts - **Applicant:** Taidoc Technology Corporation - **Product Code:** [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN.md) - **Decision Date:** Aug 25, 2009 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.1130 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use FORA P11/TD-3019 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. ## Device Story FORA P11/TD-3019 is a non-invasive, oscillometric blood pressure monitor; designed for home use by adult patients (>18 years). Device utilizes an inflatable wrist cuff to detect arterial pressure oscillations; internal sensors convert mechanical pressure signals into digital blood pressure (systolic/diastolic) and pulse rate readings. Results are displayed on an integrated screen for patient review. Device provides immediate feedback to users for monitoring cardiovascular health; facilitates self-management of blood pressure. No remote processing or cloud connectivity described. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices. ## Technological Characteristics Oscillometric measurement principle; wrist-worn inflatable cuff; digital display; battery-powered. Technical specifications and materials not detailed in provided text. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable. ## Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002 TaiDoc Technology Corporation c/o Ms. Erica Li Management Representative 6F, No. 127, Wugong 2nd Rd., Wugu Township Taipei County CHINA (TAIWAN) 24888 AUG 2 5 2009 Re: K091897 Trade Name: Blood Pressure Monitor, Model FORA P11/TD-3019 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (Two) Product Code: DXN Dated: August 11, 2009 Received: August 14, 2009 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. {1}------------------------------------------------ ## 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Attachment 2 ## Indications for Use 510(k) Number: K091897 FOR A P11/TD-3019 Blood Pressure Monitor Device Name: Indications for Use: FORA P11/TD-3019 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. 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) Page 1 of A2 ivision Sigh-Off) ular Devices Division of Cardiovaso --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K091897](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K091897) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com