510(k) · Cleared
Recalled · Class II · 2023MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003
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 Feb 12, 2010 as substantially equivalent to K071137 (Mettler Electronics Corp., 2007) after a 130-day review. Its family tree reaches back 2 generations to 1999. 15 later devices descend from it. It has been recalled once.
- Decided
- Feb 12, 2010
- Review
- 130 days
- Class
- Class II
- Product code
- IPF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K984142 (1999). 3 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- 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 deviceK093138 MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001…Shenzhen Dongdixin Technology Co., Ltd. · 2010
- Descendant · cites it directly · 8 of its ownK113010 FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd. · 2012
- Descendant · 2 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
- Descendant · 3 generations on · 5 of its ownK210021 Axon TherapyNeuralace Medical, Inc. · 2021
- Descendant · 4 generations on · 3 of its ownK230014 MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption…Tonica Elektronik A/S · 2023
- Descendant · cites it directly · 2 of its ownK171978 Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator…Shenzhen Dongdixin Technology Co., Ltd. · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K113010FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd. · 2012 · cites it directly8descendants
- K181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorShenzhen Roundwhale Technology Co., Ltd. · 2018 · 2 generations on6descendants
- K210021Axon TherapyNeuralace Medical, Inc. · 2021 · 3 generations on5descendants
- K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…Tonica Elektronik A/S · 2023 · 4 generations on3descendants
- K171978Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10Shenzhen Dongdixin Technology Co., Ltd. · 2017 · cites it directly2descendants
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) | K093138 | MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and… | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | — |
| +1 | K113010 | FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator | Famidoc Technology Co., Ltd. | 2012 | — |
| +2 | K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co., Ltd. | 2018 | — |
| +3 | K210021 | Axon Therapy | Neuralace Medical, Inc. | 2021 | — |
| +4 | K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100… | Tonica Elektronik A/S | 2023 | — |
| +1 | K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 | Shenzhen Dongdixin Technology Co., Ltd. | 2017 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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 19.6 · 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? (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…vice Class: 11 2. Predicate Device: Legally Marketed Device: Sonicator Plus 940, ME940 Manufacturer: Mettler Electronics Corp 5 10(k) Number: K071137 3. Description of Proposed Device: The MT9000 Series Stimulator, which includes models MT9000, MT9001, MT9002, MT90… | 2007 |
What descends from it? (15)
See all 153 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2023 | Class II | Z-0506-2024 | Error in labeling | The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications. |
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.
- Of its descendants, K113010 (Famidoc Technology Co., Ltd., 2012) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K071137.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
MT9000 Combo TENS/EMS/IF/MIC Stimulator For TENS 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 For IF mode 1. Symptomatic…
Read the full statement (196 words)
MT9000 Combo TENS/EMS/IF/MIC Stimulator
For TENS 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
For IF mode
1. Symptomatic relief of chronic intractable pain,
2. Post traumatic pain
3. Post surgical pain
For MIC mode
1. Symptomatic relief of chronic intractable pain,
2. Post traumatic pain
3. Post surgical pain
MT9001 TENS Stimulator
1. Symptomatic relief of chronic intractable pain,
2. Post traumatic pain
3. Post surgical pain
MT9002 EMS Stimulator
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
MT9003 IF Stimulator
1. Symptomatic relief of chronic intractable pain,
2. Post traumatic pain
3. Post Surgical pain
MT9004 MICROCURRENT Stimulator
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/K093138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093138: MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093138
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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