(242 days)
The BIA/Vitality Analyzer™ is indicated for "generally healthy" subjects of 18 to 87 years old. The BlA/Vitality Analyzer™ is intended to estimate a person's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water.
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While the provided text describes the FDA 510(k) clearance for the Vitality Analyzer™/BIA Analyzer™, it does not contain the specific acceptance criteria or details of a study (test data, sample sizes, expert qualifications, etc.) that proves the device meets those criteria.
The document is a regulatory clearance letter, confirming the device's substantial equivalence to a predicate device. It defines the intended use and regulatory classification but does not include the technical performance evaluation that would typically involve acceptance criteria and a study.
Therefore, I cannot provide the requested information in the format requested. The document primarily focuses on regulatory approval rather than detailed performance evaluation.
§ 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.