# K991613: SW Ultrasound, Models 331, 311, 333

- Pathway: 510(k) (Traditional)
- Applicant: Starbene
- Decided: Dec 8, 2000 after 578 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 K961250 (1996). 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)
- K961250: Dynatron 125 Ultrasound, Dynatronics Corp. (1996) Summary page 1.

## Indications for use
IS A THERAPEUTICAL ULTRASONIC DIATHERMY DEVICE FOR PROFESSIONAL USE TO APPLY THERAPEUTIC DEEP HEAT FOR SELECTED MEDICAL CONDITIONS .

Source page: https://510kreport.com/device/K991613
Methodology: https://510kreport.com/methodology