Search Results

The BCM is used as body fat analyzer that estimate the percent body fat (%BF), percent lean body mass(%LBM) and percent total body water (TBW%) with the use of BIA (bioelectrical impedance analysis). The SAM or Stayhealthy Activity Monitor [ a triaxial accelerometer and 3axis, gyroscope equipped calorie tracker- (CT2)], is a device that is sold as companion device with the BCM and is used to track the number of calories used by the client. The device is intended for use by healthy subjects ages 8-92.

Not Found

The provided text is a 510(k) premarket notification letter for the Stayhealthy Body Composition Monitor-BCM. It states that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance reports, study designs, sample sizes, expert qualifications, ground truth establishment, or any of the specific details requested in your prompt (points 1-9). The letter is primarily an FDA clearance notification, not a technical report detailing the device's validation.

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device