510(k) · Cleared
ClearedManaSport+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manamed, Inc. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Mar 8, 2023 as substantially equivalent to K210284 (Manamed, Inc., 2022) and 1 other predicate after a 233-day review. Its family tree reaches back 3 generations to 2012. 1 later device descends from it.
- Decided
- Mar 8, 2023
- Review
- 233 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K120171 (2012). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK120171 Accusonic AdvantageMetron Medical Australia, Pty, Ltd. · 2012
- 2 generations backK130978 ZTX Ultrasonic Diathermy DeviceZetroz, Inc. · 2013
- 1 generation backK191568 sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC · 2020
- This deviceK222098 ManaSport+Manamed, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK240788 Ultrasound StimulatorJkh Health Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K240788Ultrasound StimulatorJkh Health Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K120171 | Accusonic Advantage | Metron Medical Australia, Pty, Ltd. | 2012 | — |
| −2 | K130978 | ZTX Ultrasonic Diathermy Device | Zetroz, Inc. | 2013 | — |
| −1 | K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems, LLC | 2020 | — |
| 0 (this device) | K222098 | ManaSport+ | Manamed, Inc. | 2023 | — |
| +1 | K240788 | Ultrasound Stimulator | Jkh Health Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 10.4 · 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 |
|---|---|---|---|
| * | K210284 | ManaSportSummary page 4…ation Name: Ultrasonic diathermy Device Class: II Use: Prescription 3. Predicate device Primary Predicate Device: ManaSport 510(k) Number: K210284 Clearance Date: April 26, 2022 Submitter: ManaMed, Inc. Predicate Device: sam 2.0 Long Duration Ultrasound Sys… | 2022 |
| * | K191568 | sam 2.0 Long Duration Ultrasound SystemSummary page 4…Number: K210284 Clearance Date: April 26, 2022 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 The ManaSp… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240788 | Ultrasound Stimulator | 2025 | 0 |
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 11 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K240788 (Jkh Health Co., Ltd., 2025) has gone furthest, with 0 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. 2023, 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 as stated in the FDA summary.
https://510kreport.com/device/K222098 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222098: ManaSport+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222098
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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