# K220002: Dexus Prosthetics System (Model: MSL1, MSR1)

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Qiangnao Technology Co.,Ltd
- Decided: Sep 9, 2022 after 248 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: 2 generations back to K032833 (2003). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123795: Axon-Bus Prosthetic System, Otto Bock Austria (2014) Summary page 5.

## Most influential descendants
- K242326: Wave Electrode (AE02-60); Wave Electrode (AE02-50) (2025), 1 descendant of its own
- K262654: Dexus Prosthetic System (MSL2, MSR2) (2026), 0 descendants of its own
- K260453: Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (2026), 0 descendants of its own

## Indications for use
The Dexus Prosthetic System is to be used exclusively for external prosthetic fittings of the upper limbs.

Source page: https://510kreport.com/device/K220002
Methodology: https://510kreport.com/methodology