# K060843: Modification to Health Buddy Appliance

- Pathway: 510(k) (Special)
- Applicant: Health Hero Network, Inc.
- Decided: Apr 20, 2006 after 23 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K864318 (1987). 25 ancestors in all.
39 later devices descend from it; 6 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K030419: Viterion 100 Telehealth Monitor, Viterion Telehealthcare, LLC (2003) Summary page 2.

## Most influential descendants
- K063612: Modification to Health Buddy Appliance (2006), 30 descendants of its own
- K080798: Intel Health Guide, Model: PHS6000 (2008), 25 descendants of its own
- K083862: Medapps 2.0 Remote Patient Monitoring System (2009), 12 descendants of its own
- K083115: Modification to Intel Health Guide, Model PHS6000 (2008), 12 descendants of its own
- K101178: Modification to Intel Health Guide PHS6000 (2010), 11 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/K060843
Methodology: https://510kreport.com/methodology