(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.
§ 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).