# K083677: Physioglove for Use with Physioglove ES1

- Pathway: 510(k) (Traditional)
- Applicant: Commwell, Ltd.
- Decided: Mar 10, 2009 after 89 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Tapuz Medical Technology's ECG Electrodes Apron: named in the summary without a submission number
- (no number) IneedMD 12-Lead Glove: named in the summary without a submission number

## Indications for use
The 12 lead glove is designed to configure the ECG electrodes in a single unit for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 33.5 - 46.5 inches (85 - 118 cms).

Source page: https://510kreport.com/device/K083677
Methodology: https://510kreport.com/methodology