# K053546: Sonicator 740, Model ME 740

- Pathway: 510(k) (Abbreviated)
- Applicant: Mettler Electronics Corp.
- Decided: May 4, 2006 after 135 days
- Product code: IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5300
- 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. The FDA summary names no predicate by number.

## Indications for use
Ultrasound delivered to the body using an efficient couplant provides deep heating effects to body tissues. Ultrasound delivered at a frequency of 1 MHz penetrates to a depth of approximately 5 centimeters while ultrasound at a frequency of 3.3 or 3.2 MHz penetrates tissue to a depth of approximately 1-2 cm. When therapeutic ultrasound is delivered to the body at intensities capable of generating a deep tissue temperature increase, some or all of the following effects may occur: 1. Pain relief 2. Reduction of muscle spasm 3. Localized increase in blood flow 4. Increase range of motion of contracted joints using heat and stretch techniques.

Source page: https://510kreport.com/device/K053546
Methodology: https://510kreport.com/methodology