# K063484: Patient Data Handler & Devices (PDH&D)

- Pathway: 510(k) (Traditional)
- Applicant: Intermed Advisors, Inc.
- Decided: Dec 22, 2006 after 35 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). 30 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 35 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 1.
- K060843: Modification to Health Buddy Appliance, Health Hero Network, Inc. (2006) Summary page 1.
- K043217: A&D Medical UA-767PBT Digital Blood Pressure Monitor, A&D Engineering, Inc. (2005) Summary page 1.

## Most influential descendants
- K083221: Aidera Diasend (2009), 3 descendants of its own
- K101806: Aidera Diasend System (2010), 2 descendants of its own
- K132618: Onetouch Reveal (2013), 0 descendants of its own
- K122361: T:Connect Data Management System (2013), 0 descendants of its own

## Indications for use
The PDH&D is indicated for use in non-clinical settings to collect and transmit historical patient data to healthcare professionals to help support effective management of their patients.

Source page: https://510kreport.com/device/K063484
Methodology: https://510kreport.com/methodology