# K131899: SW-Therm

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongdixin Technology Co., Ltd.
- Decided: Mar 14, 2014 after 262 days
- Product code: IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5290
- 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 SW-Therm, Model STIOOI, is intended to deliver energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as: 1) Relieving pain; 2) Reducing muscle spasm; 3) Increasing range of motion of contracted joints using heat and stretch techniques; and 4) Increasing blood flow to tissues in the treatment area.

Source page: https://510kreport.com/device/K131899
Methodology: https://510kreport.com/methodology