# K022776: Ness System

- Pathway: 510(k) (Special)
- Applicant: Ness-Neuromuscular Electrical Stimulation Systems
- Decided: Sep 11, 2002 after 21 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- 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 K813008 (1981). 5 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952273: Handmaster NMS1, Neuromusclar Electrical Stimulation Systems, Ltd. (1996) Summary page 2.
- K982482: Handmaster NMS1, N.E.S.S. Nuromuscular Electrical Stimulation Syst (1998) Summary page 2.

## Most influential descendants
- K103343: L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) (2011), 15 descendants of its own
- K123972: Walkaide System (2013), 14 descendants of its own
- K140886: Walkaide System (2014), 10 descendants of its own
- K162407: L300 Go System (2017), 9 descendants of its own
- K173682: L300 Go System (2018), 7 descendants of its own

## Indications for use
The NESS System is intended to be used for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.

Source page: https://510kreport.com/device/K022776
Methodology: https://510kreport.com/methodology