(29 days)
The TRANSTEK Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
The TRANSTEK Glass Body Fat Analyzer uses BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water and bone mass. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer. This method simultaneously calculates your personal weight, body fat, total body water, bone mass and muscle mass, giving you a more accurate reading of your overall health and fitness. This scale stores the personal data of up to 4 or 8 users. As well as being an analyzer, this device can be used as a conventional scale.
The provided text describes a 510(k) premarket notification for the TRANSTEK Glass Body Fat Analyzer. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information regarding acceptance criteria, a specific study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment, expert involvement, or any multi-reader multi-case comparative effectiveness study.
The document states:
"The subject devices have all features of the predicate device, Transtek Glass Body Analyzer (Model GBF-950) except the new features and the power source voltage of the device. These differences do not affect the safety and effectiveness of the subject devices. BIA (Bioelectrical Impedance Analysis) technology is same as what is used in Glass Body Analyzer (Model GBF-950). Thus, the subject devices are substantially equivalent to the predicate devices."
This indicates that the submission relies on the established safety and effectiveness of the predicate device, rather than providing new performance data against specific acceptance criteria for the new models.
Therefore, I cannot populate the requested table and information based on the provided text.
§ 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.