# K040121: Dermawave 5000 Combi Max System

- Pathway: 510(k) (Traditional)
- Applicant: Dermawave, LLC
- Decided: Mar 17, 2004 after 57 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
Longest line of descent: 2 generations back to K923076 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982317: Vectra Combo, Chattanooga Group, Inc. (1999) Summary page 1.
- K982324: Vectra Pro Models 2 and 4, Chattanooga Group, Inc. (1999) Summary page 1.
- K935728: Dynatron 150, Dynatronics Corp. (1994) Summary page 1.
- K001166: Ultra V Therapeutic Ultrasound, Excel Tech., Ltd. (2000)

## Indications for use
Stimulation, relaxing, and/or repeatedly contracting muscles by passing electrical currents through electrodes contacting the affected body area in the medical specialties of physical medicine, general and plastic surgery and neurology and/or for use in applying therapeutic deep heat for selected medical conditions such as relief of pain, muscle spasms and joint contractures in the medical specialty of physical medicine. The indications of the DermaWave 5000 Combi Max System also include the treatment and 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 rauscles to prevent venous thrombosis, symptomatic relief of chronic intractable pain, management of pain associated with post-traumatic or post-operative conditions using electrical stimulation and are indicated for the application of therapeutic deep heat for the treatment of selected medical conditions such as relief of pain, muscle spasms and joint contractures, relief of pain muscle spasms and joint contractures that may be associated with adhesive capsulitis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of chronic and sub-chronic pain and joint contractures resulting from capsular tightness and capsular scarring using ultrasound. The DermaWave 5000 Combi Max System is also indicated for use in providing topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

Source page: https://510kreport.com/device/K040121
Methodology: https://510kreport.com/methodology