# K123642: Muscle Stimulation System

- Pathway: 510(k) (Traditional)
- Applicant: Niveus Medical, Inc.
- Decided: Mar 29, 2013 after 123 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: 4 generations back to K010782 (2001). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083105: Kneehab XP Conductive Garment, Type 411, Bio-Medical Research, Ltd. (2009) Summary page 1.
- K080661: Models Tens 7000, Ems 7500 and Twin Stim, Koalaty Products, Inc. (2008) Summary page 1.
- K070888: Combi 8 Max, Cec Electronica S.R.L. (2008) Summary page 1.

## Most influential descendants
- K150742: Muscle Stimulation System 110 (2015), 0 descendants of its own

## Indications for use
The Niveus Medical Muscle Stimulation System 110 is indicated for: * Maintaining or increasing range of motion of the knee joint * Prevention or retardation of disuse atrophy in the quadriceps * Muscle re-education of the quadriceps * Relaxation of muscle spasms * Increasing local blood circulation

Source page: https://510kreport.com/device/K123642
Methodology: https://510kreport.com/methodology