(131 days)
The blood pressure meter Models: XJ-2001AC, XJ-2002AS and XJ-2003A are non-invasive blood pressure measurement systems which are intended to measure the diastolic and systolic blood pressure, pulse rate of the adult individual through using inflatable cuff at home. The cuff circumference is limited to 8.6614 inches to 12.60 inches.
Blood Pressure Meter Model: XJ-2001AC, XJ-2002AS and XJ-2003A
The provided text is an FDA 510(k) clearance letter and an Indications for Use statement for a blood pressure meter. It does not contain the acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications based on the provided text. This document confirms the device's clearance based on substantial equivalence to a predicate device, not on specific performance data presented in a study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2007
Shanghai Korea Economic and Trade Company c/o Mr. Zhao J. Yu Rome. 902, No. 15, Lane 28 Qingjiang, China 200233
Re: K062893
Trade Name: Blood Pressure Meter Model: XJ-2001AC, XJ-2002AS and XJ-2003A Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: November 16, 2006 Received: January 11, 2007
Dear Mr. Yu:
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 or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 – Mr. Yu
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/cdrl/industry/support/index.html.
Sincerely vours.
B. Bernadina 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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K0462893
Shanghai Kodea Economic and Trade Development Limited Company.
510(k) Submission Application
Indications for Use
510(k) Number (if known): K062893 Device Name: Blood Pressure Meter Model: XJ-2001AC. Blood Pressure Meter Model: XJ-2002AS and
Blood Pressure Meter Model: XJ-2003A
Indications for Use:
The blood pressure meter Models: XJ-2001AC, XJ-2002AS and XJ-2003A are non-invasive blood pressure measurement systems which are intended to measure the diastolic and systolic blood pressure, pulse rate of the adult individual through using inflatable cuff at home. The cuff circumference is limited to 8.6614 inches to 12.60 inches.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, office of Device Evaluation (ODE)
Blumuma
Division Sign-Offi Division of Cardiovascular De 510(k) Numbe
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§ 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).