# K050595: FT2000 Sequencer for  Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Midwest Development
- Decided: May 23, 2005 after 76 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: 2 generations back to K912178 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972244: NT2000, Bio-Medical Research, Ltd. (1998) Summary page 1.

## Indications for use
When used in combination with a listed stimulator, such as the NT2000 manufactured by Bio-Medical Research Ltd., the Midwest Development FT2000 Sequencer provides electrical neuromuscular stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, or to maintain or increase range of motion. Sequencing provided by the FT2000 directs the stimulator signal from the stimulator device to selected patient electrode sites without modifying the original signal characteristics. The FT2000 permits treatment in user selected time sequences of up to 24 pairs of electrodes by having 12 pairs on each side of the body. The C12000 Software allows the user to set treatment times for each electrode pair.

Source page: https://510kreport.com/device/K050595
Methodology: https://510kreport.com/methodology