(224 days)
The higi Station is intended to be used by the general public to measure blood pressure, pulse, body weight, and calculate Body Mass Index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can also choose to store or send the data to a personal physician or healthcare professional. The user has to be at least 13 years old.
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This document is a FDA 510(k) clearance letter for the higi Station, a device intended for general public use to measure blood pressure, pulse, body weight, and calculate Body Mass Index. It does not contain the detailed acceptance criteria or a study summary that proves the device meets specific performance criteria.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it is considered as safe and effective as a device that was on the market before the 1976 Medical Device Amendments or has been reclassified. However, the 510(k) clearance process itself often relies on submission of performance data, but the details of those studies and specific acceptance criteria are not included in this FDA clearance letter.
Therefore, I cannot provide the requested information from this document. The document only specifies the device name, K-number, regulation number, product code, and its intended use, along with general regulatory requirements.
§ 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).