510(k) · Cleared
ClearedOrthosonics Duo-Son Ultrasound Diathermy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.L. Mcintosh & Assoc., Inc. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Jun 16, 1997 as substantially equivalent to K883228 (Mettler Electronics Corp., 1988) after a 153-day review. Its family tree reaches back 1 generation to 1988. 2 later devices descend from it.
- Decided
- Jun 16, 1997
- Review
- 153 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K883228 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK883228 Sonicator 720 (Model ME720)Mettler Electronics Corp. · 1988
- This deviceK970131 Orthosonics Duo-Son Ultrasound Diathermy DeviceC.L. Mcintosh & Assoc., Inc. · 1997
- Descendant · cites it directly · 1 of its ownK081075 Painshield MDNano Vibronix, Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK221210 PainShield MD PLUSNanovibronix, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883228 | Sonicator 720 (Model ME720) | Mettler Electronics Corp. | 1988 | — |
| 0 (this device) | K970131 | Orthosonics Duo-Son Ultrasound Diathermy Device | C.L. Mcintosh & Assoc., Inc. | 1997 | — |
| +1 | K081075 | Painshield MD | Nano Vibronix, Ltd. | 2008 | — |
| +2 | K221210 | PainShield MD PLUS | Nanovibronix, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K883228 | Sonicator 720 (Model ME720)Summary page 1…red: January 14, 1997 A. LEGALLY MARKETED PREDICATE DEVICES The Orthosonics Duo-Son Ultrasound Diathermy Device is substantially equivalent to the Mettler Model ME-720 (K883228). B. ~~ DEVICE DESCRIPTION The Orthosonics Duo-Son Ultrasound Diathermy Device consists of a two-channel power module which gen… | 1988 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081075 | Painshield MD | 2008 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K081075 (Nano Vibronix, Ltd., 2008) has gone furthest, with 1 descendant 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.
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 Orthosonics Duo-Son Ultrasound Diathermy Device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.
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/K970131 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970131: Orthosonics Duo-Son Ultrasound Diathermy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970131
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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