# K800380: Fes Orthosis Model NO. 2000

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Mar 17, 1980 after 24 days
- Product code: GZI (Stimulator, Neuromuscular, External Functional)
- Device class: 2
- Regulation: 21 CFR 882.5810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K974514: External Functional Neuromuscular Stimulator (1998), 23 descendants of its own
- K050991: The Odfs Dropped Foot Stimulator (2005), 20 descendants of its own
- K053468: NESS L300 (2006), 17 descendants of its own
- K102115: Odfs Pace (2011), 16 descendants of its own
- K080219: Modification to:Ness L300 (2008), 16 descendants of its own

Source page: https://510kreport.com/device/K800380
Methodology: https://510kreport.com/methodology