# K130952: Precision One Lifecare; Detecto; Detecto

- Pathway: 510(k) (Traditional)
- Applicant: Precision One Lifecare, Ltd.
- Decided: Sep 26, 2013 after 174 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: 4 generations back to K930599 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090479: Tanita Body Composition Analyzer, Model SC-331, Tanita Corporation of America (2009) Summary page 2.

## Indications for use
The Precision One Lifecare and Detecto Body Fat scales measure weight and use bioelectrical impedance analysis (BIA) technology to estimate and keep a record of body fat percent, total body water percent, bone mass percent, and muscle mass percent. The scales also provide a daily calorie intake recommendation and a fitness assessment. The scales are intended for use in the home/domestic setting only. Estimated body fat percent is intended for use on individuals 7-17 years old (Healthy Children) and 18-80 years old (Healthy Adults). Estimated body water percent, estimated muscle mass percent, estimated bone mass percent, and calorie intake are intended for use on individuals 18-80 years old. Children under 7 years old and adults over 80 years old can use the scales for normal weighing mode only. The scales are not intended for diagnosis. The specific model names and numbers for these scales are: Precision One Lifecare model numbers - 7853, 7840, 7841, 7850, 7851, and 7856. Detecto model numbers - D221, D222, D223, D212, D207, D201, D202, D203, D204, and D205

Source page: https://510kreport.com/device/K130952
Methodology: https://510kreport.com/methodology