# K024013: Sun-Rain Ultrasonic Therapy, SU-100

- Pathway: 510(k) (Traditional)
- Applicant: Sun-Rain System Corp.
- Decided: Oct 31, 2003 after 331 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K090542: Sun-Rain Ultrasonic Therapy Models, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 (2009), 0 descendants of its own

## Indications for use
The SU-100 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/K024013
Methodology: https://510kreport.com/methodology