# K081499: Health Manager, Version 1.1

- Pathway: 510(k) (Traditional)
- Applicant: Biocomfort Diagnostics GmbH & Co. KG
- Decided: Jan 16, 2009 after 232 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K864318 (1987). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072698: Confidant 2.5, Confidant, Inc. (2007) Summary page 1.

## Indications for use
The Biocomfort Health Manager is a software for local home PC or Laptop in a non clinical environment to collect historical data from defined peripheral devices The software will receive, store and display measurements from home use diagnostic medical devices such blood pressure meter and a body composition analyser The data will not be used for medical diagnosis It is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgement

Source page: https://510kreport.com/device/K081499
Methodology: https://510kreport.com/methodology