# K981449: SD-956 Ultrasound Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Skylark Device Co., Ltd.
- Decided: Dec 11, 1998 after 233 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SD-956 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/K981449
Methodology: https://510kreport.com/methodology