# K103026: Electro Sensor -Body Composition

- Pathway: 510(k) (Traditional)
- Applicant: Ld Technology, LLC
- Decided: Mar 29, 2011 after 168 days
- Product code: MNW (Analyzer, Body Composition)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K830292 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070999: BC (Body Composition Software), Rjl Systems, Inc. (2007) Summary page 2.
- K050395: Impedimed - Body Composition Analysis, Impedimed Pty, Ltd. (2005). Our reading of the summary gave K052395, FDA’s number for Sterile Equipment Covers (Volcano Corporation). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DF50 Body Composition Analysis”.

## Indications for use
Calculation and Historical Tracking of. * Actual Resistance * Actual Reactance * Actual Impedance * Actual Phase Angle (PA) * Estimated Body Fat Mass (FM) * Estimated Fat Free Mass (FFM) * Estimated Total Body Water (TBW) * Estimated Intra-Cellular Water (ICW) * Estimated Extra-Cellular Water (ECW) * Estimated Basal Metabolic Rate (BMR) * Estimated Daily Energy Expenditure (DEE) * Actual Body Mass Index (BMI) The device is not intended for use for diagnosis. The actual resistance, reactance, impedance and phase angle have no clinical utility and are for calculation of body composition only. The data are stored in PC in the Backup system of the E.S-BC software. As regard to the estimated TWB , ICW and ECW , the device is intended for use on healthy subjects' over 12 years old and under 80 years old and non-Hispanic whites, non-Hispanic blacks and Mexican Americans in the US population. As regard to the estimated FM and FFM, the device is intended for use on healthy subjects over 19 years old and under 63 years old and Caucasian and Hispanic Americans in the US population. The device is for over-the-counter use

Source page: https://510kreport.com/device/K103026
Methodology: https://510kreport.com/methodology