# K133703: Physioglove ET System

- Pathway: 510(k) (Traditional)
- Applicant: Commwell R&D, Ltd.
- Decided: Aug 18, 2014 after 258 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: 9 generations back to K921669 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042254: PMP4 Selfcheck Ecg, Card Guard Scientific Survival, Ltd. (2005) Summary page 5.
- K103791: Physioglove ES with Ecg Analysis, Commwell, Ltd. (2011) Summary page 5.

## Indications for use
The PhysioGlove ET is intended for self-testing by patients and by health care professionals at home and at medical settings. This 12-lead electrocardiogram (ECG), allows remote patients to display and transmit their ECG data to medical professionals via a mobile platform (communication device) to a remote server. Specifically, the PhysioGlove ET is intended for patients who are concerned about their heart health and have the following problems that are suggestive of abnormal heart function: The system only provides waveform parameters for healthcare provider interpretation and does not provide suggested interpretations. Skipped beats Pounding heart (palpitations) Heart racing or irregular pulse Lightheadedness or faintness Chest discomfort Shortness of breath High risk for heart problems History of heart problems Recipient of heart medications

Source page: https://510kreport.com/device/K133703
Methodology: https://510kreport.com/methodology