# K012823: Modification to Handmaster

- Pathway: 510(k) (Traditional)
- Applicant: Ness-Neuromuscular Electrical Stimulation Systems
- Decided: Nov 14, 2001 after 90 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 1.
- K982482: Handmaster NMS1, N.E.S.S. Nuromuscular Electrical Stimulation Syst (1998) Summary page 1.
- K010837: Handmaster, Neuromusclar Electrical Stimulation Systems, Ltd. (2001) Summary page 1.
- K972997: AM800 Automove Emg Triggered Electrical Muscle Stimulation, Dan Med, Inc. (1997) Summary page 1.

## 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 hemiplegia due to stroke, it is also intended to provide hand active range of motion and hand function.

Source page: https://510kreport.com/device/K012823
Methodology: https://510kreport.com/methodology