# K111482: Sonicator Plus 920

- Pathway: 510(k) (Special)
- Applicant: Mettler Electronics Corp.
- Decided: Aug 25, 2011 after 90 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 K984142 (1999). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071137: Sonicator Plus 940, Model ME940, Mettler Electronics Corp. (2007) Summary page 2.

## Most influential descendants
- K182108: Portable Electro-Stimulation Therapy Device (2019), 0 descendants of its own

## Indications for use
Therapeutic Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as; 1. Relief of pain, muscle spasms and joint contractures: 2. 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 3. Relief of pain, muscle spasms and joint contractures resulting from: * Capsular tightness * Capsular tightening 4-Pole Interferential, 2-Pole Interferential, TENS and Microcurrent waveforms 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic pain 3. Post-surgical pain EMS, TENS, Hi Volt and Russian waveforms 1. Relaxation of muscle spasms 2. Increase local blood circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion 6. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis DC (Direct Current) Relaxation of muscle spasms

Source page: https://510kreport.com/device/K111482
Methodology: https://510kreport.com/methodology