# K112520: US-101L, US-103S

- Pathway: 510(k) (Traditional)
- Applicant: Ito Co., Ltd.
- Decided: Oct 26, 2011 after 56 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: 2 generations back to K984142 (1999). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032793: US-100 Portable Ultrasound Therapy Unit, Ito Co., Ltd. (2003) Summary page 1.
- K024307: Dermosonic Non-Invasive Subdermal Therapy System, Sybaritic, Inc. (2003). Our reading of the summary gave K024367, FDA’s number for Sinclair Wound and Skin Emulsion (Sinclair Pharmaceuticals, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Dermosonic Non-Invasive Subdermal Therapy System”.

## Most influential descendants
- 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-101L, US-103S are 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/K112520
Methodology: https://510kreport.com/methodology