# K050670: Sensor Mobile SM 100 Vitaphone 1001R Remos

- Pathway: 510(k) (Traditional)
- Applicant: Tms Telemedizinische Systeme GmbH
- Decided: Mar 30, 2005 after 15 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: 1 generation back to K963904 (1997). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963904: P.H.D. - Personal Heart Device Model 5258, Heart Alert, Inc. (1997) Summary page 2.

## Most influential descendants
- K053378: Loop Recorder  Vitaphone, 3100 Series (2006), 2 descendants of its own
- K100383: Vitaphone. Model 100 BT (2010), 1 descendant of its own
- K082013: Clue Medical and Clue Medical Basic (2008), 1 descendant of its own
- K151013: Vitaphone Tele ECG Loop Recorder (2015), 0 descendants of its own
- K083630: Clue Medical and Clue Medical Basic (2009), 0 descendants of its own

## Indications for use
Symptomatic disturbances of cardiac rhythm such as palpitations, fatigue, heart racing, fluttering, chest discomfort or pain.

Source page: https://510kreport.com/device/K050670
Methodology: https://510kreport.com/methodology