# K073334: Ohmniscan NG

- Pathway: 510(k) (Traditional)
- Applicant: Christine Valmy, Inc.
- Decided: Aug 22, 2008 after 268 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: 1 generation back to K002835 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002835: Bodystat, Bodystat, Ltd. (2001) Summary page 3.

## Indications for use
Ohmnnsiscan NG is a non prescription device and is used on healthy subjects with no known disease or condition, and is identified as used for generally healthy adults (18-65). It is used to estimate the following: * Lmpedance(Z in ohns) * Total body water (TBW in L and in %) * Lean Mass(LM in KG) * Fat Mass (FM in KG and %) * Basal Metabolism(Kcal) * Daily energy needs(Kcal) * B.M.I. (Body Mass Index).

Source page: https://510kreport.com/device/K073334
Methodology: https://510kreport.com/methodology