510(k) · Cleared
ClearedDU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alfa Tech Medical Systems, Ltd. · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Cleared on Dec 9, 2005 as substantially equivalent to K013192 (Mettler Electronics Corp., 2001) after a 105-day review. Its family tree reaches back 2 generations to 1999. 2 later devices descend from it.
- Decided
- Dec 9, 2005
- Review
- 105 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K984142 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- 1 generation backK013192 Sonicator Plus 930, Model ME 930Mettler Electronics Corp. · 2001
- This deviceK052340 DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator SystemAlfa Tech Medical Systems, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK160378 BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK063728 TNN-DU810 Non-Invasive Subdermal Therapy SystemAlfa Tech Medical Systems, Ltd. · 2007
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 |
|---|---|---|---|---|---|
| −2 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| −1 | K013192 | Sonicator Plus 930, Model ME 930 | Mettler Electronics Corp. | 2001 | — |
| 0 (this device) | K052340 | DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System | Alfa Tech Medical Systems, Ltd. | 2005 | — |
| +1 | K160378 | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) | Brh Medical, Ltd. | 2017 | — |
| +1 | K063728 | TNN-DU810 Non-Invasive Subdermal Therapy System | Alfa Tech Medical Systems, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K013192 | Sonicator Plus 930, Model ME 930Summary page 4…tem for comparison Claimed device Predicate device 510K# K013192 Device Name DU857 Dual Frequency Ultrasound Sonicator Plus 930 Therapy and… | 2001 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K160378 (Brh Medical, Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K013192.
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.
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. Localized increase of blood flow
4. Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation:
1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
2. Temporary relaxation of muscle spasm
3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
4. Increase of blood flow in the treatment area.
5. Prevention or retardation of disuse atrophy in post-injury type conditions
6. Muscle re-education
7. Maintaining or increasing range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052340 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052340: DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052340
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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