# K103791: Physioglove ES with Ecg Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Commwell, Ltd.
- Decided: Oct 21, 2011 after 298 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: 8 generations back to K921669 (1993). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050674: Physioglove ES, Commwell, Ltd. (2006) Summary page 1.
- K092369: 12SL Ecg Analysis Program, Ge Medical Systems Information Technologies (2010) Summary page 1.

## Most influential descendants
- K133703: Physioglove ET System (2014), 0 descendants of its own

## Indications for use
The PhysioGlove ES Model I is a reusable 12-lead diagnostic EGG examination system. The system can be used with 12-lead cables or the PhysioGlove device. When used with the PhysioGlove, it is intended to conduct an electrocardiogram. The diagnostic and automatic measurement features are not available. When used with a 12-lead cable, it is intended for use in resting diagnostic electrocardiograph examination of adults. The PhysioGlove ES Model I 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 provides waveform parameters and EGG analysis for healthcare provider interpretation. The PhysioGlove ES Model I EGG Analysis Program assists the physician in measuring and interpreting resting 12-lead EGGs for rhythm and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.

Source page: https://510kreport.com/device/K103791
Methodology: https://510kreport.com/methodology