# K080091: Modification to:Health Buddy Appliance

- Pathway: 510(k) (Special)
- Applicant: Health Hero Network, Inc.
- Decided: Feb 5, 2008 after 22 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: 12 generations back to K864318 (1987). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070543: Modification to Health Buddy Appliance, Health Hero Network, Inc. (2007) Summary page 2.
- K063612: Modification to Health Buddy Appliance, Health Hero Network, Inc. (2006) Summary page 2.
- K060843: Modification to Health Buddy Appliance, Health Hero Network, Inc. (2006) Summary page 2.
- K050567: Health Buddy Appliance, Health Hero Network, Inc. (2005) Summary page 2.
- K042273: Modification to Health Buddy with Device Connectivity, Health Hero Network, Inc. (2004) Summary page 2.
- K040086: Health Buddy with Buddylink, Health Hero Network, Inc. (2004) Summary page 2.
- K993128: Healthbuddy with Device Connect [Glucose Meter], Health Hero Network, Inc. (1999) Summary page 2.
- K040966: Modification to Carematix Wellness System, Carematix, Inc. (2004) Summary page 2.
- K061502: MEDIC4ALL Telemedicine System VMS-01, Medic4all (Israel), Ltd. (2006) Summary page 2.
- K062127: MEDIC4ALL Telemedicine System, Model VMS-01 (Nibp), Medic4all (Israel), Ltd. (2006) Summary page 2.
- K062662: Telemedicine System Model VMS-01, Medic4all (Israel), Ltd. (2006) Summary page 2.

## Most influential descendants
- K091021: Modification to Medicompass Connect (2009), 0 descendants of its own

## Indications for use
Health Buddy® Appliance is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.

Source page: https://510kreport.com/device/K080091
Methodology: https://510kreport.com/methodology