510(k) · Cleared
ClearedUS-100 Portable Ultrasound Therapy Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ito Co., Ltd. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Oct 9, 2003 as substantially equivalent to K984142 (Mettler Electronics Corp., 1999) after a 30-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.
- Decided
- Oct 9, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984142 (1999). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- This deviceK032793 US-100 Portable Ultrasound Therapy UnitIto Co., Ltd. · 2003
- Descendant · cites it directly · 4 of its ownK112520 US-101L, US-103SIto Co., Ltd. · 2011
- Descendant · 2 generations on · 3 of its ownK161628 JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK241099 Plasonic (Plasonic)Hironic Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK260397 SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK251334 New Doublo 2.0Hironic Co., Ltd. · 2025
Most influential descendants
Showing 5 of 5 · See all- K112520US-101L, US-103SIto Co., Ltd. · 2011 · cites it directly4descendants
- K161628JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc. · 2016 · 2 generations on3descendants
- K241099Plasonic (Plasonic)Hironic Co., Ltd. · 2024 · 3 generations on2descendants
- K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd. · 2026 · 4 generations on0descendants
- K251334New Doublo 2.0Hironic Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| 0 (this device) | K032793 | US-100 Portable Ultrasound Therapy Unit | Ito Co., Ltd. | 2003 | — |
| +1 | K112520 | US-101L, US-103S | Ito Co., Ltd. | 2011 | — |
| +2 | K161628 | JAS Pulse (TM) Ultrasonic Therapy | Bonutti Research, Inc. | 2016 | — |
| +3 | K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | 2024 | — |
| +4 | K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | 2026 | — |
| +4 | K251334 | New Doublo 2.0 | Hironic Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number ME 994Summary page 1…GALLY MARKETED PREDICATE DEVICES The US-I00 Ultrasound Therapy Unit is substantially equivalent to the ultrasound section of the Sonicator Plus 992 (K984142)by Mettler. B. DEVICE DESCRIPTION The US-I00 Ultrasound Therapy Unit consists of a main unit and two… | 1999 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112520 | US-101L, US-103S | 2011 | 4 |
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?
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.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032793: US-100 Portable Ultrasound Therapy Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032793
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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