510(k) · Cleared
ClearedBRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brh Medical, Ltd. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Aug 25, 2017 as substantially equivalent to K013192 (Mettler Electronics Corp., 2001) and 1 other predicate after a 562-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Aug 25, 2017
- Review
- 562 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K984142 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- 2 generations backK013192 Sonicator Plus 930, Model ME 930Mettler Electronics Corp. · 2001
- 1 generation backK052340 DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator SystemAlfa Tech Medical Systems, Ltd. · 2005
- This deviceK160378 BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| −2 | K013192 | Sonicator Plus 930, Model ME 930 | Mettler Electronics Corp. | 2001 | — |
| −1 | K052340 | DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator System | Alfa Tech Medical Systems, Ltd. | 2005 | — |
| 0 (this device) | K160378 | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) | Brh Medical, Ltd. | 2017 | — |
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 |
|---|---|---|---|
| * | K013192 | Sonicator Plus 930, Model ME 930Summary page 6…(Combination ultrasound and muscle stimulator) Mettler Electronics Corp. K013192 Secondary Predicate Device: Trade Name The DU857 Dual Frequency Ultrasound Therapy and Muscl… | 2001 |
| * | K052340 | DU857 Dual Frequency Ultrasound Therapy and Muscle Stimulator SystemSummary page 6…sound Therapy and Muscle Stimulator System Alfa Tech Medical Systems Ltd. K052340 Device Description: The BRH-A2 CUSEFS is comprised of the following main components: • A system console including softw… | 2005 |
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 18 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K013192.
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. 2017, 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?
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
TARGET POPULATION
Adult patients
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160378: BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160378
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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