# K982830: Forte, Models CPS 400 Combo, CPS 200 Combo

- Pathway: 510(k) (Traditional)
- Applicant: Chattanooga Group, Inc.
- Decided: Nov 6, 1998 after 87 days
- Product code: IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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.

## Most influential descendants
- K091615: Med Contour (2010), 2 descendants of its own
- K160075: Accent XL (2016), 0 descendants of its own
- K161502: MC1 Plus (2016), 0 descendants of its own

## Indications for use
Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis; bursitis with slight calcification, myositis and soft tissue injuries. The Forte CPS Combo, while using any of the applicators available for this device, can provide therapeutic deep heating between 40° and 45 °C in all of its operating modes. For VMS, Russian, & Monophasic Hi-Volt - Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local circulation Muscle re-education Maintaining or increasing range of motion Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis For Interferential, Microcurrent, and Premod Symptomatic relief of chronic, intractable p Management of pain associated with post-traumatic or post-operative conditions

Source page: https://510kreport.com/device/K982830
Methodology: https://510kreport.com/methodology
