# K223738: Alpha Control Liner System (ACLS)

- Pathway: 510(k) (Special)
- Applicant: Coapt
- Decided: Jan 11, 2023 after 28 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K032833 (2003). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191083: COMPLETE CONTROL System Gen2, Coapt, LLC (2019) Summary page 5.

## Most influential descendants
- K242326: Wave Electrode (AE02-60); Wave Electrode (AE02-50) (2025), 1 descendant of its own
- K260453: Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (2026), 0 descendants of its own

## Indications for use
The Alpha Control Liner System is to be used exclusively for exoprosthetic fittings of the upper limbs.

Source page: https://510kreport.com/device/K223738
Methodology: https://510kreport.com/methodology