510(k) · Cleared
ClearedSonicstimu Combo Therapeutic Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Dongdixin Technology Co., Ltd. · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Cleared on Nov 21, 2012 after a 302-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Nov 21, 2012
- Review
- 302 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK120217 Sonicstimu Combo Therapeutic DeviceShenzhen Dongdixin Technology Co., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK150436 ComboRehabShenzhen Dongdixin Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK244041 Ultrasound Therapy Workstation (XMS-UET2)Xemis Medical Technology (Shenzhen) Co., Ltd. · 2025
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 |
|---|---|---|---|---|---|
| 0 (this device) | K120217 | Sonicstimu Combo Therapeutic Device | Shenzhen Dongdixin Technology Co., Ltd. | 2012 | — |
| +1 | K150436 | ComboRehab | Shenzhen Dongdixin Technology Co., Ltd. | 2015 | — |
| +2 | K244041 | Ultrasound Therapy Workstation (XMS-UET2) | Xemis Medical Technology (Shenzhen) Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IMG? 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 IMG device
- #1 K244041 Ultrasound Therapy Workstation (XMS-UET2)score 10.7 · 3 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K150436 | ComboRehab | 2015 | 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?
- Of its descendants, K150436 (Shenzhen Dongdixin Technology Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All IMG devicesIMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IMG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMG
226in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMG
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMG
9in 2025
MAUDE reports naming product code IMG, 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 | 3 | 110 | 0 | 0 |
| 2008 | 0 | — | 2 | 37 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 3 | 226 | 0 | 21 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Therapeutic Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1. Pain relief, muscle spasms and joint contractures. 2. Relief of pain, muscle spasms and joint contractures that may be associated with: * Adhesive capsulitis * Bursitis with slight calcification * Myositis * Soft tissue injuries * Shortened tendons due to past injuries and scar tissues 3. Relief of sub-chronic…
Read the full statement (149 words)
Therapeutic Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
1. Pain relief, muscle spasms and joint contractures.
2. Relief of pain, muscle spasms and joint contractures that may be associated with:
* Adhesive capsulitis
* Bursitis with slight calcification
* Myositis
* Soft tissue injuries
* Shortened tendons due to past injuries and scar tissues
3. Relief of sub-chronic, chronic pain and joint contractures resulting from:
" Capsular tightness
* Capsular scarring
For TENS, Interferential, premodulated(IFC), NMS and Microcurrent
1. Symptomatic relief of chronic intractable pain
2. Post-traumatic acute pain
3. Post-surgical acute pain
Additionally for EMS, NMS, Hi-Volt and Russian:
1. Relaxation of Muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Maintaining or increasing range of motion
6. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K120217 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120217: Sonicstimu Combo Therapeutic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120217
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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