# K032833: Myosystem with Customizing

- Pathway: 510(k) (Traditional)
- Applicant: Otto Bock Healthcare LP
- Decided: Sep 23, 2003 after 12 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
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K032933: MyoSystem. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K123795: Axon-Bus Prosthetic System (2014), 13 descendants of its own
- K162891: Complete Control System (2017), 7 descendants of its own
- K220002: Dexus Prosthetics System (Model: MSL1, MSR1) (2022), 3 descendants of its own
- K191083: COMPLETE CONTROL System Gen2 (2019), 3 descendants of its own
- K223738: Alpha Control Liner System (ACLS) (2023), 2 descendants of its own

## Indications for use
Adult External Electric Upper Extremity System

Source page: https://510kreport.com/device/K032833
Methodology: https://510kreport.com/methodology