510(k) · Cleared
ClearedSonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number ME 994
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mettler Electronics Corp. · IPF Stimulator, Muscle, Powered
Cleared on Feb 9, 1999 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 34 later devices descend from it.
- Decided
- Feb 9, 1999
- Review
- 83 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 3 citing it directly.
- This deviceK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- Descendant · cites it directly · 19 of its ownK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
- Descendant · 2 generations on · 15 of its ownK093138 MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001…Shenzhen Dongdixin Technology Co., Ltd. · 2010 · Recalled
- Descendant · cites it directly · 11 of its ownK013192 Sonicator Plus 930, Model ME 930Mettler Electronics Corp. · 2001
- Descendant · 3 generations on · 8 of its ownK113010 FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd. · 2012
- Descendant · 4 generations on · 6 of its ownK181688 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS…Shenzhen Roundwhale Technology Co., Ltd. · 2018
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K071137Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007 · cites it directly19descendants
- K093138MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003Shenzhen Dongdixin Technology Co., Ltd. · 2010 · 2 generations on15descendants
- K013192Sonicator Plus 930, Model ME 930Mettler Electronics Corp. · 2001 · cites it directly11descendants
- K113010FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd. · 2012 · 3 generations on8descendants
- K181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorShenzhen Roundwhale Technology Co., Ltd. · 2018 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K093138 | MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and… | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | 1 |
| +1 | K013192 | Sonicator Plus 930, Model ME 930 | Mettler Electronics Corp. | 2001 | — |
| +3 | K113010 | FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator | Famidoc Technology Co., Ltd. | 2012 | — |
| +4 | K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (34)
See all 343 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?
- Of its descendants, K071137 (Mettler Electronics Corp., 2007) has gone furthest, with 19 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
Therapeutic Ultrasound Pain relief Reduction of muscle spasm Localized increase in blood flow Increase range of motion of contracted joints using heat and stretch techniques. Neuromuscular Stimulation Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, Premodulated and Microcurrent waveforms) Temporary relaxation of muscle spasm, (all waveforms except Microcurrent) Prevention of…
Read the full statement (112 words)
Therapeutic Ultrasound
Pain relief
Reduction of muscle spasm
Localized increase in blood flow
Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation
Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential, Premodulated and Microcurrent waveforms)
Temporary relaxation of muscle spasm, (all waveforms except Microcurrent)
Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles, (all waveforms except Microcurrent)
Increase of blood flow in the treatment area, (all waveforms except Microcurrent)
Prevention or retardation of disuse atrophy in post-injury type conditions, (all waveforms except Microcurrent)
Muscle re-education, (all waveforms except Microcurrent)
Maintaining or increasing range of motion, (all waveforms except Microcurrent)
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984142 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984142: Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number ME 994.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984142
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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