# K091430: Care Pal, Model CPW-10X

- Pathway: 510(k) (Traditional)
- Applicant: Digio2 International Co., Ltd.
- Decided: Aug 21, 2009 after 99 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: 8 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)
- K042273: Modification to Health Buddy with Device Connectivity, Health Hero Network, Inc. (2004) Summary page 1.

## Indications for use
Care Pal (Model no. CPW-10X) 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. The product is not intended to provide automated treatment decisions nor for use as a substitute for a health care professional's judgement.

Source page: https://510kreport.com/device/K091430
Methodology: https://510kreport.com/methodology