# K032793: US-100 Portable Ultrasound Therapy Unit

- Pathway: 510(k) (Traditional)
- Applicant: Ito Co., Ltd.
- Decided: Oct 9, 2003 after 30 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 K984142 (1999). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984142: Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number ME 994, Mettler Electronics Corp. (1999) Summary page 1.

## Most influential descendants
- K112520: US-101L, US-103S (2011), 4 descendants of its own
- K161628: JAS Pulse (TM) Ultrasonic Therapy (2016), 3 descendants of its own
- K241099: Plasonic (Plasonic) (2024), 2 descendants of its own
- K260397: SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) (2026), 0 descendants of its own
- K251334: New Doublo 2.0 (2025), 0 descendants of its own

## Indications for use
The US-100 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.

Source page: https://510kreport.com/device/K032793
Methodology: https://510kreport.com/methodology