510(k) · Cleared
ClearedCT2011 Sonicstimu Pain Relief 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 Jan 14, 2010 as substantially equivalent to K071137 (Mettler Electronics Corp., 2007) after a 141-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Jan 14, 2010
- Review
- 141 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K984142 (1999). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- 1 generation backK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
- This deviceK092627 CT2011 Sonicstimu Pain Relief DeviceShenzhen Dongdixin Technology Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| −1 | K071137 | Sonicator Plus 940, Model ME940 | Mettler Electronics Corp. | 2007 | — |
| 0 (this device) | K092627 | CT2011 Sonicstimu Pain Relief Device | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 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? (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 |
|---|---|---|---|
| * | K071137 | Sonicator Plus 940, Model ME940Summary page 2…Code: IMQj GZJ, LIH Device Class: 11 Legally Marketed Device: Sonicator Pius 940, ME940 Manufacturer: Mettler Electronics Corp 510(k) Number: K071 137 3. Description of' Proposed Device: The CT2O011 SonicStimnu Pain Relief Device is comprised of following main compo… | 2007 |
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 11 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K071137.
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. 2010, 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
1. Pain relief
2. Reduction of muscle spasm
3. Joint contractures
Transcutaneous Electrical Nerve Stimulation
1. Symptomatic relief of chronic intractable pain
2. Post-traumatic pain
3. Post-surgical pain
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/K092627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092627: CT2011 Sonicstimu Pain Relief Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092627
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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