(28 days)
The Body analysis scale, Model BF 66 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.
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This document is an FDA 510(k) clearance letter for the "Body analysis scale, Model BF 66." It primarily states that the device is substantially equivalent to a predicate device and outlines regulatory responsibilities. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based solely on the provided text. The document is administrative in nature rather than a technical study report.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.