(29 days)
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .
The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .
H&L Full Automatic (NIBP) Blood Pressure Monitor Trade Name : HL888RA
The provided text is a 510(k) premarket notification decision letter from the FDA to Health & Life Corporation, Ltd. for their HL888RA noninvasive blood pressure measurement system. The document confirms that the device is substantially equivalent to legally marketed predicate devices and is approved for market.
Crucially, the acceptance criteria and the study proving the device meets those criteria are not detailed in this document. This letter is a regulatory approval, not a technical report or study summary. Therefore, I cannot extract the specific information requested about the acceptance criteria or the study from the provided text.
The document does offer some general information about the device and its intended use:
- Device Name: H&L Full Automatic (NIBP) Blood Pressure Monitor, Trade Name: HL888RA
- Regulation Name: Noninvasive blood pressure measurement system
- Method: Measures Systolic, Diastolic blood pressure and heart rate using the oscillometric method.
- Intended Use: For adult patients whose arm circumference is between 24-32cm (approx. 8.7" to 12.6").
- Type of Use: Over-the-counter use.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or the 510(k) submission itself which would contain the performance data and acceptance criteria used for substantial equivalence.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • U.S." arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with three parallel lines above them, resembling a stylized eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2003
Health & Life Coporation, Ltd. c/o Mrs. Susan Chen 9F. No. 186. Jian Yi Road Chung Ho City, Taipei, Hsien China (Taiwan) 235
Re: K031835
Trade Name: HL888RA Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: May 2, 2003 Received: June 2, 2003
Dear Mrs. Chen:
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.
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
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Page 2 -- Mrs. Susan Chen
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Elisa D'Arrigo Sw
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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510(k) Number (if known): K031835
Device Name : H&L Full Automatic (NIBP) Blood Pressure Monitor Trade Name : HL888RA
Indications For Use
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .
The intended for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/2/Picture/6 description: The image shows the text "Prescription USE" on the first line and "(Per 21 CFR 801.109)" on the second line. The word "USE" has a line going through it, indicating that it has been crossed out. The text is in a simple, sans-serif font and is likely part of a form or document.
Prescription Use Only
OR
Over-The-Counter Use( √ )
(Optional Format 1-2)
(Division Sign-Off)
Division of Cordigugggulor Dodeso
510(k) Number
7
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).