# K223605: ControlSeal Electrode (ELSB)

- Pathway: 510(k) (Special)
- Applicant: Coapt
- Decided: Dec 30, 2022 after 28 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K942921 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190416: Dome Electrode, Coapt, LLC (2019) Summary page 5.

## Recalls of this device
- Oct 2, 2023 · Class II · Z-0204-2024: Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

## Indications for use
The ControlSeal Electrodes are intended for non-invasive use with recording and monitoring equipment of Electromyography (EMG).

Source page: https://510kreport.com/device/K223605
Methodology: https://510kreport.com/methodology