# K161628: JAS Pulse (TM) Ultrasonic Therapy

- Pathway: 510(k) (Abbreviated)
- Applicant: Bonutti Research, Inc.
- Decided: Nov 10, 2016 after 150 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: 3 generations back to K984142 (1999). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112520: US-101L, US-103S, Ito Co., Ltd. (2011) Summary page 4.
- K131309: Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZ, Ibramed Equipamentos Medicos (2014) Summary page 4.
- K121059: Soleoline, Soleo Stim, Soleo Sono, Soleo Sonostim, Zimmer Medizinsystems GmbH (2012) Summary page 4.

## Most influential descendants
- 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
Application of therapeutic ultrasound for: Pain. Pain relief, muscle spasms, and joint contractures. Relief of pain, muscle spasms, and joint contractures that may be associated with: Adhesive capsulitis, Bursitis with slight calcification, Myositis, Soft tissue injuries, and Shortened tendons due to past injuries and scar tissues. Relief of pain, muscle spasms, and joint contractures resulting from: Capsular tightness, and Capsular scarring. Localized increase in blood flow. Increased range of motion of contracted joints using heat and stretch techniques.

Source page: https://510kreport.com/device/K161628
Methodology: https://510kreport.com/methodology