# K090542: Sun-Rain Ultrasonic Therapy Models, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900

- Pathway: 510(k) (Traditional)
- Applicant: Sun-Rain System Corp.
- Decided: Oct 23, 2009 after 235 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
Longest line of descent: 1 generation back to K024013 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024013: Sun-Rain Ultrasonic Therapy, SU-100, Sun-Rain System Corp. (2003) Summary page 1.

## Indications for use
The SUN-RAIN Ultrasonic Therapy generates deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Source page: https://510kreport.com/device/K090542
Methodology: https://510kreport.com/methodology
