510(k) · Cleared
ClearedUltrasound Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jkh Health Co., Ltd. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Jun 4, 2025 as substantially equivalent to K222098 (Manamed, Inc., 2023) and 1 other predicate after a 439-day review. Its family tree reaches back 4 generations to 2012.
- Decided
- Jun 4, 2025
- Review
- 439 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K120171 (2012). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK120171 Accusonic AdvantageMetron Medical Australia, Pty, Ltd. · 2012
- 3 generations backK130978 ZTX Ultrasonic Diathermy DeviceZetroz, Inc. · 2013
- 2 generations backK191568 sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC · 2020
- 1 generation backK222098 ManaSport+Manamed, Inc. · 2023
- This deviceK240788 Ultrasound StimulatorJkh Health Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K120171 | Accusonic Advantage | Metron Medical Australia, Pty, Ltd. | 2012 | — |
| −3 | K130978 | ZTX Ultrasonic Diathermy Device | Zetroz, Inc. | 2013 | — |
| −2 | K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems, LLC | 2020 | — |
| −1 | K222098 | ManaSport+ | Manamed, Inc. | 2023 | — |
| 0 (this device) | K240788 | Ultrasound Stimulator | Jkh Health Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 K230472 Sonopuls 190score 10.1 · 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? (2)
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 |
|---|---|---|---|
| * | K222098 | ManaSport+Summary page 5…ine Product Code: IMI, PFW Regulation Number: 21 CFR 890.5300 Device Class: II Use: Prescription 3. Predicate device Primary Predicate Device: ManaSport+ 510(k) Number: K222098 Clearance Date: March 8, 2023 Submitter: ManaMed, Inc. Predicate Device: sam 2.0 Long Duration Ultrasound System 510(k) Number:… | 2023 |
| * | K191568 | sam 2.0 Long Duration Ultrasound SystemSummary page 5…evice: ManaSport+ 510(k) Number: K222098 Clearance Date: March 8, 2023 Submitter: ManaMed, Inc. Predicate Device: sam 2.0 Long Duration Ultrasound System 510(k) Number: K191568 Clearance Date: March 6, 2020 Submitter: ZetrOZ Systems, LLC 4. Description of Subject Device As a portable and rechargeable pre… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
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. 2025, 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?
Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Apply continuous movement of ultrasound for: 1. Pain. 2. Pain relief, muscle spasms, and joint contractures. 3. Relief of pain, muscle spasms, and joint contractures that may be associated with: »…
Read the full statement (133 words)
Apply stationary use of ultrasound to:
Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
Apply continuous movement of ultrasound for:
1. Pain.
2. Pain relief, muscle spasms, and joint contractures.
3. 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.
4. Relief of pain, muscle spasms, and joint contractures resulting from:
» Capsular tightness, and
» Capsular scarring.
5. Localized increase in blood flow.
6. Increased range of motion of contracted joint 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/K240788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240788: Ultrasound Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240788
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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