# K013770: Modification to: Winner ST-2 Stimulator

- Pathway: 510(k) (Special)
- Applicant: Rich-Mar Corp.
- Decided: Jan 18, 2002 after 66 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
Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms: Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Maintaining or increasing range of motion. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms: 1. Symptomatic relief of chronic intractable pain. 2. Management of pain associated with post-traumatic or post operative conditions.

Source page: https://510kreport.com/device/K013770
Methodology: https://510kreport.com/methodology