(261 days)
The KLOCK Blood Pressure Monitor is to be used by adults as a Home Health Care device to monitor Blood Pressure (systolic and diastolic) and the Pulse rate at home. The Blood Pressure Measurement is obtained by the use of the oscillometric method, meaning that the monitor detects the blood's movement through the artery in the wrist and converts the movements into digital readings. The KLOCK is not intended to be used by people who have circulatory problems, such as arrhythmia, or if pregnant.
Watch Style Wrist Digital Blood Pressure Monitor
The provided document is a 510(k) clearance letter from the FDA for a "Watch Style Wrist Digital Blood Pressure Monitor." It states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot provide the requested information based on the input document. The letter is a regulatory approval, not a scientific study report.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).