# K012848: Winner CM4 Combination Unit

- Pathway: 510(k) (Traditional)
- Applicant: Rich-Mar Corp.
- Decided: Oct 25, 2001 after 63 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- 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
Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions: 1) Relief of pain 2) Muscle Spasms 3) Joint contractures But NOT for the treatment of malignancies Microcurrent output is indicated for the following conditions: 1) Symptomatic relief of chronic, intractable pain. 2) Management of pain associated with posi-traumatic or posi-operative conditions. This device is indicated for the following conditions: 1) Relaxation of muscle spasms. 2) Prevention or retardation of disuse atrophy. 3) Increasing local blood circulation. 4) Muscle re-education. 5) Maintaining or increasing range of motion. 6) Immediate post-surgical stimulation of calf muscles 1o prevent venous thrombosis. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. (Quadpolar Interferential and Microamperage Pulsed Current) 1) Symptomatic relief of chronic, intractable pain, 2) Management of pain associated with post-traumatic or posi-operative conditions.

Source page: https://510kreport.com/device/K012848
Methodology: https://510kreport.com/methodology