510(k) · Cleared
ClearedCombo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Dongdixin Technology Co., Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Oct 2, 2017 as substantially equivalent to K093138 (Shenzhen Dongdixin Technology Co., Ltd., 2010) and 1 other predicate after a 94-day review. Its family tree reaches back 3 generations to 1999. 2 later devices descend from it.
- Decided
- Oct 2, 2017
- Review
- 94 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K984142 (1999). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- 2 generations backK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
- 1 generation backK093138 MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001…Shenzhen Dongdixin Technology Co., Ltd. · 2010 · Recalled
- This deviceK171978 Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator…Shenzhen Dongdixin Technology Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK231440 Combo Electrotherapy DeviceShenzhen Roundwhale Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK213197 MyOnyx SystemThought Technology, Ltd. · 2022
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 |
|---|---|---|---|---|---|
| −3 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| −2 | K071137 | Sonicator Plus 940, Model ME940 | Mettler Electronics Corp. | 2007 | — |
| −1 | K093138 | MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and… | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | 1 |
| 0 (this device) | K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 | Shenzhen Dongdixin Technology Co., Ltd. | 2017 | — |
| +1 | K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co., Ltd. | 2023 | — |
| +1 | K213197 | MyOnyx System | Thought Technology, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K093138 | MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003Summary page 6…Device Class: II 2. Predicate Device: Legally Marketed Device: MT9000 Series Electro-Stimulator 510(k) Number: K093138 Manufacturer: Shenzhen Dondixin Technology Co., Ltd. Legally Marketed Device:… | 2010 |
| * | K071137 | Sonicator Plus 940, Model ME940Summary page 6…turer: Shenzhen Dondixin Technology Co., Ltd. Legally Marketed Device: Sonicator® Plus 940, ME940 510(k) Number: K071137 Manufacturer: Mettler Electronics Corp. 3. Description of Proposed Device: MT9000, LT7102 an… | 2007 |
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 18 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K231440 (Shenzhen Roundwhale Technology Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K093138.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
Combo Stimulator MT9000 For TENS/IF/MIC mode 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain For EMS mode 1. Relaxation of muscle spasm. 2. Increase of local blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis Combo Stimulator LT7102 For…
Read the full statement (145 words)
Combo Stimulator MT9000
For TENS/IF/MIC mode
1. Symptomatic relief of chronic intractable pain
2. Post traumatic pain
3. Post surgical pain
For EMS mode
1. Relaxation of muscle spasm.
2. Increase of local blood flow circulation
3. Prevention or retardation of disuse atrophy
4. Muscle re-education
5. Maintaining or increasing range of motion.
6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis
Combo Stimulator LT7102
For TENS/IF/MIC mode
1. Symptomatic relief of chronic intractable pain
2. Post traumatic pain
3. Post surgical pain
For EMS/RUSS mode
1. Relaxation of muscle spasm.
2. Increase of local blood flow circulation
3. Prevention or retardation of disuse atrophy
4. Muscle re-education
5. Maintaining or increasing range of motion.
6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis
TENS Stimulator InTENSity 10
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/K171978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171978: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171978
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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