510(k) · Cleared
ClearedJAS Pulse (TM) Ultrasonic Therapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonutti Research, Inc. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Nov 10, 2016 as substantially equivalent to K112520 (Ito Co., Ltd., 2011) and 2 other predicates after a 150-day review. Its family tree reaches back 3 generations to 1999. 3 later devices descend from it.
- Decided
- Nov 10, 2016
- Review
- 150 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K984142 (1999). 10 ancestors in all, the oldest K954411 (1996). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- 2 generations backK032793 US-100 Portable Ultrasound Therapy UnitIto Co., Ltd. · 2003
- 1 generation backK112520 US-101L, US-103SIto Co., Ltd. · 2011
- This deviceK161628 JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK241099 Plasonic (Plasonic)Hironic Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK260397 SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251334 New Doublo 2.0Hironic Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| −2 | K032793 | US-100 Portable Ultrasound Therapy Unit | Ito Co., Ltd. | 2003 | — |
| −1 | K112520 | US-101L, US-103S | Ito Co., Ltd. | 2011 | — |
| 0 (this device) | K161628 | JAS Pulse (TM) Ultrasonic Therapy | Bonutti Research, Inc. | 2016 | — |
| +1 | K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | 2024 | — |
| +2 | K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026 | — |
| +2 | K251334 | New Doublo 2.0 | Hironic Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IMI device
- #1 K240788 Ultrasound Stimulatorscore 10.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112520 | US-101L, US-103SSummary page 4…For Use In Applying Therapeutic Deep Heat (21 CFR 890.5300) Regulatory Class: II Product Code: IMI III. PREDICATE DEVICE(S) Ito US-101L (K112520) – Primary Predicate IBRAMED Sonopulse Compact 1 MHz (K131309) Zimmer Soleo Sono (K121059)… | 2011 |
| * | K131309 | Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZSummary page 4…Regulatory Class: II Product Code: IMI III. PREDICATE DEVICE(S) Ito US-101L (K112520) – Primary Predicate IBRAMED Sonopulse Compact 1 MHz (K131309) Zimmer Soleo Sono (K121059) 372 ===… | 2014 |
| * | K121059 | Soleoline, Soleo Stim, Soleo Sono, Soleo SonostimSummary page 4…roduct Code: IMI III. PREDICATE DEVICE(S) Ito US-101L (K112520) – Primary Predicate IBRAMED Sonopulse Compact 1 MHz (K131309) Zimmer Soleo Sono (K121059) 372 IV. DEVICE DESCRIPTION… | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241099 | Plasonic (Plasonic) | 2024 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K241099 (Hironic Co., Ltd., 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All IMI devicesIMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · IMI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMI
150in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMI
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMI
2in 2025
MAUDE reports naming product code IMI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 2 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 3 | 150 | 0 | 2 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161628: JAS Pulse (TM) Ultrasonic Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161628
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026