# K041146: Control Solutions, Inc., Model CS3102 HVG

- Pathway: 510(k) (Traditional)
- Applicant: Control Solutions, Inc.
- Decided: Jun 8, 2004 after 36 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
Relaxation of muscle spasm Increasing local blood circulation Maintaining or increasing range of motion Preventing or retarding disuse atrophy Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Federal law restricts this device to sale by or on the order of a practitioner so licensed by the law of the state in which he/she practices to use or order the use of the device.

Source page: https://510kreport.com/device/K041146
Methodology: https://510kreport.com/methodology