(140 days)
The Scaleman Body Fat Scales - Models in "Family Model List 1A" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
The Scaleman Body Fat Scales - Models in "Family Model List 1B" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, bone mass and muscle mass using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
Body composition analyzer/scale that utilizes a “foot-to-foot” bioelectrical impedance (BIA) technology to determine internal body composition.
The provided text describes the "Scaleman Body Fat Scales" and its substantial equivalence to a predicate device, the "Tanita Innerscan Body Composition Monitor, K040778". However, it does not clearly define specific acceptance criteria in a quantitative manner or provide a detailed study that explicitly proves the device meets such criteria with numerical performance data.
Instead, the document states: "A comparative clinical study, submitted in this notification (Section 20), showed that body fat (%) and FFM (kg) in normal and athlete modes, body water (%) muscle mass (kg), bone mass (kg) and weight (kg) measured or estimated by test and predicate devices were significantly correlated (P
§ 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.