# K993420: Control Solutions Inc, Model CS3101

- Pathway: 510(k) (Traditional)
- Applicant: Control Solutions, Inc.
- Decided: Jul 19, 2000 after 281 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Interferential Current Therapy Modes: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. Neuro-Muscular Stimulator Modes: Relaxation of muscle spasm, increasing local blood circulation, maintaining or increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Source page: https://510kreport.com/device/K993420
Methodology: https://510kreport.com/methodology