# K050674: Physioglove ES

- Pathway: 510(k) (Traditional)
- Applicant: Commwell, Ltd.
- Decided: Apr 25, 2006 after 406 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974351 (1998). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030535: Ekgcard System, Qrs Diagnostic, LLC (2003) Summary page 2.

## Most influential descendants
- K103791: Physioglove ES with Ecg Analysis (2011), 1 descendant of its own
- K133703: Physioglove ET System (2014), 0 descendants of its own

## Indications for use
The PhysioGlove ES Model I is a reusable 12-Lead diagnostic ECG examination system. It is intended for use in resting diagnostic electrocardiograph examination of adults. It is intended for use in physician offices, hospitals, outpatient clinics, or similar settings by or on the order of a physician or similarly qualified healthcare professional. The device only provides waveform parameters for healthcare provider interpretation and does not itself provide suggested interpretations.

Source page: https://510kreport.com/device/K050674
Methodology: https://510kreport.com/methodology