# K130777: Inbody

- Pathway: 510(k) (Traditional)
- Applicant: Biospace Corporation Limited
- Decided: Nov 25, 2013 after 249 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: 8 generations back to K830292 (1983). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110689: Inbody, Biospace Corporation Limited (2011) Summary page 1.
- K123228: Inbody 770, Inbody 570, Inbody S10, Inbody H20/Inbody H20(B), Biospace Corporation Limited (2013) Summary page 1.

## Indications for use
For use only in healthy subjects for Measurement of: Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECWITBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA). Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph. Weight Control, Fat Control, Muscle Control Actual: Weight. Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for lnBody72O], Reactance Values [only for lnBody72Ol. Phase Angle [only for lnBady72O]

Source page: https://510kreport.com/device/K130777
Methodology: https://510kreport.com/methodology