# K031900: Handmaster

- Pathway: 510(k) (Special)
- Applicant: Ness-Neuromuscular Electrical Stimulation Systems
- Decided: Aug 8, 2003 after 50 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
Longest line of descent: 3 generations back to K813008 (1981). 6 ancestors in all.
35 later devices descend from it; 1 cites it directly.
0 of 42 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.
- K010837: Handmaster, Neuromusclar Electrical Stimulation Systems, Ltd. (2001) Summary page 2.

## Most influential descendants
- K080950: Stiwell MED4 (2009), 34 descendants of its own
- K110179: Incontrol (2012), 21 descendants of its own
- K134020: Intonemv (2014), 10 descendants of its own
- K141158: APEX (2014), 9 descendants of its own
- K181497: HPM-6000UF (2018), 6 descendants of its own

## Indications for use
The Handmaster 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. In patients suffering from upper limb paralysis due to C5 spinal cord injury or hemiplegic patients due to stroke, it is also intended to provide hand active range of motion and hand function,

Source page: https://510kreport.com/device/K031900
Methodology: https://510kreport.com/methodology