# K964554: Personal Telemedicine Module

- Pathway: 510(k) (Traditional)
- Applicant: American Telecare, Inc.
- Decided: Dec 17, 1996 after 34 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: 1 generation back to K952882 (1996). 1 ancestor in all.
37 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952882: Personal Telemedicine System, American Telecare, Inc. (1996) Summary page 1.

## Most influential descendants
- K973873: Digital Personal Telemedicine Module, Digital PTM 1 (1997), 36 descendants of its own
- K034046: RNK Telephonic Stethoscope, Model TR-1 (2004), 32 descendants of its own
- K072026: RNK Electronic Stethoscope (2007), 29 descendants of its own
- K102893: PCP/PC Stethoscope (2011), 26 descendants of its own
- K160401: Tyto Stethoscope (2016), 21 descendants of its own

## Indications for use
The Personal Telemedicine Module is intended to be used solely as a monitoring device, whereby a health care professional can communicate with the patient between visits to gather blood pressure and pulse readings, and to listen to the patient's heart and lung sounds.

Source page: https://510kreport.com/device/K964554
Methodology: https://510kreport.com/methodology