# K191083: COMPLETE CONTROL System Gen2

- Pathway: 510(k) (Special)
- Applicant: Coapt, LLC
- Decided: May 24, 2019 after 30 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: 3 generations back to K032833 (2003). 3 ancestors in all.
3 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)
- K162891: Complete Control System, Coapt, LLC (2017) Summary page 4.

## Most influential descendants
- K223738: Alpha Control Liner System (ACLS) (2023), 2 descendants of its own
- 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 COMPLETE CONTROL System Gen2 is to be used exclusively for external prosthetic fittings of the upper limbs.

Source page: https://510kreport.com/device/K191083
Methodology: https://510kreport.com/methodology