# K083174: Healthepod

- Pathway: 510(k) (Traditional)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Dec 17, 2009 after 416 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963725 (1997). 6 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963725: Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified), Card Guard, Ltd. (1997) Summary page 2.
- K042254: PMP4 Selfcheck Ecg, Card Guard Scientific Survival, Ltd. (2005) Summary page 2.
- K061800: Clever TD-1112 Ear/Skin/Surface IR Thermometer, Taidoc Technology Corporation (2006) Summary page 2.

## Most influential descendants
- K093976: Raisin Personal  Monitor (2010), 12 descendants of its own
- K131009: Proteus Patch, Ingestible Sensor (Accessory) (2013), 6 descendants of its own
- K133263: Proteus Patch, Proteus Ingestible Sensor (Accessory) (2014), 4 descendants of its own
- K110015: Vitalsens, Aingeal, V-Pod (2011), 4 descendants of its own
- K150494: Proteus Digital Health Feedback Device (2015), 3 descendants of its own

## Indications for use
The HealthePod is a medical device designed for self-testing. It comprises the following medical features: * ECG 1-lead * Heart rate * Body temperature

Source page: https://510kreport.com/device/K083174
Methodology: https://510kreport.com/methodology