U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM
Device Facts
| Record ID | K112216 |
|---|---|
| Device Name | U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM |
| Applicant | Taidoc Technology Corporation |
| Product Code | DXN · Cardiovascular |
| Decision Date | Dec 22, 2011 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
Intended Use
The U-RIGHT TD-3128 Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.
Device Story
The U-RIGHT TD-3128 Blood Pressure Monitoring System is an oscillometric device for non-invasive measurement of systolic/diastolic blood pressure and pulse rate. The system comprises a digital monitor and an inflatable upper arm cuff. It is intended for over-the-counter use by adults aged 18 and older. The device operates by inflating the cuff to occlude the artery and measuring pressure oscillations during deflation to calculate blood pressure and pulse values. Results are displayed on the monitor for user review. The device is a modified version of the predicate, featuring a new physical appearance and the removal of a voice-output function.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by software verification, validation, and design validation confirming performance, safety, and effectiveness equivalent to the predicate device.
Technological Characteristics
Oscillometric non-invasive blood pressure measurement. System consists of a monitor and inflatable upper arm cuff. Shares fundamental circuit design and materials with the predicate device. Software-based processing for oscillometric signal analysis.
Indications for Use
Indicated for adults 18 years and older for non-invasive measurement of systolic and diastolic blood pressure and pulse rate via an upper arm cuff.
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.
Predicate Devices
- FORA P20/U-RIGHT TD-3132 Blood Pressure Monitoring System (K092106)
Related Devices
- K112274 — U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM · Taidoc Technology Corporation · Dec 21, 2011
- K120634 — U-RIGHT TD-3124 BLOOD PRESSURE MONITORING SYSTEM · Taidoc Technology Corporation · Jul 3, 2012
- K100658 — U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM · Taidoc Technology Corporation · Jul 9, 2010
- K090058 — YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB · Ya Horng Electronic Co., Ltd. · Apr 22, 2009
- K081159 — HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES · Harvard Medical Devices , Ltd. · Aug 8, 2008
Submission Summary (Full Text)
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# Section 11. 510(k) Summary
### 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
K112216 The Assigned 510(k) number is:
- l. Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, Taiwan
Correspondence: Linda Ko Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1158 Fax: +886-2-6625-0288 Email: kolinda@taidoc.com.tw
Date of submission: 07/28/2011
- 2. Device name:
Proprietary name: U-RIGHT TD-3128 Blood Pressure Monitoring System
Regulatory information:
| A. Regulation section: | 21 CFR §870.1130, Noninvasive blood pressure<br>measurement system |
|------------------------|--------------------------------------------------------------------|
| B. Classification: | Class II (Blood Pressure Measurement System) |
| C. Product Code: | DXN, System, Measurement, Blood-Pressure, Non-Invasive |
- 74, Cardiovascular Blood Pressure Measurement System D. Panel:
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3. Intended Use:
The U-RIGHT TD-3128 Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.
- 4. Device Description:
The kit of U-RIGHT TD-3128 Blood Pressure Monitoring System consists of two main products: the Blood Pressure Monitor and the pressure cuff. The product has been designed and tested to work together as a system to produce accurate blood pressure measurements.
- 5. Substantial Equivalence Information:
Predicate device name: A.
FORA P20/U-RIGHT TD-3132 Blood Pressure Monitoring System
- Predicate K number: K092106 B.
C. Comparison with predicate:
The modified U-RIGHT TD-3128 Blood Pressure Monitoring System has the following similarities to the predicate device:
- same operating principle,
- same fundamental scientific technology, 그
- . incorporate the same basic circuit design,
- incorporate the same materials,
- . same shelf life
- . packaged using the same materials, and
- . manufactured by the same process.
The modifications encompass:
- 동 Removed the function of speaking
- . Modification of the devices physical appearance
- Labeling change due to the above modifications
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- 6. Test Principle:
The measurement is by using oscillometric, non-invasive blood pressure (systolic, diastolic blood pressure and pulse rate) measuring technology.
- 7. Performance Characteristics:
The U-RIGHT TD-3128 Blood Pressure Monitoring System has the same performance characteristics as the predicate device.
Software verification and validation, and design validation confirmed that the performance, safety and effectiveness of the U-RIGHT TD-3128 Blood Pressure Monitoring System are equivalent to the predicate device.
- 8. Conclusion:
Based on the information provided in this submission, the U-RIGHT TD-3128 Blood Pressure Monitoring System is substantially equivalent to the predicate FORA P20/U-RIGHT TD-3132 Blood Pressure Monitoring System.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 2 2011
TaiDoc Technology Corporation c/o Ms. Linda Ko Regulatory Affairs Specialist 6F, No. 127, Wugong 2nd Rd. Wugu Township, New Taipei City TAIWAN 24888
Re: K112216
Trade/Device Names: TaiDoc U-RIGHT TD-3128 Blood Pressure Monitoring System Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: November 16, 2011 Received: November 22, 2011
#### Dear Ms. Ko:
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 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. Linda Ko
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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## Section 8.
## Indications for Use
K112216 510(k) Number:
Device Name: U-RIGHT TD-3128 Blood Pressure Monitoring System
Indications for Use:
The U-RIGHT TD-3128 Blood Pressure Monitoring System is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of ODRH, Office of Device Evaluation (ODE)
Atutste/m Blackman
Division Sign-Off/ 12/22/2004
Division Sign-Off/ 12/22/0
Office of Device Evaluation (ODE)
510(k) K1122/6
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