510(k) · Cleared
ClearedFDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Famidoc Technology Co., Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Dec 21, 2012 as substantially equivalent to K093138 (Shenzhen Dongdixin Technology Co., Ltd., 2010) after a 437-day review. Its family tree reaches back 3 generations to 1999. 8 later devices descend from it.
- Decided
- Dec 21, 2012
- Review
- 437 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K984142 (1999). 4 ancestors in all. 8 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 deviceK113010 FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd. · 2012
- Descendant · cites it directly · 6 of its ownK181688 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS…Shenzhen Roundwhale Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 5 of its ownK210021 Axon TherapyNeuralace Medical, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK230014 MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption…Tonica Elektronik A/S · 2023
- Descendant · 3 generations on · 1 of its ownK233364 Axon TherapyNeuralace Medical, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK250309 BTL-199BTL Industries, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K181688R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS StimulatorShenzhen Roundwhale Technology Co., Ltd. · 2018 · cites it directly6descendants
- K210021Axon TherapyNeuralace Medical, Inc. · 2021 · 2 generations on5descendants
- K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…Tonica Elektronik A/S · 2023 · 3 generations on3descendants
- K233364Axon TherapyNeuralace Medical, Inc. · 2024 · 3 generations on1descendant
- K250309BTL-199BTL Industries, Inc. · 2025 · 4 generations on0descendants
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 | 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) | K113010 | FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator | Famidoc Technology Co., Ltd. | 2012 | — |
| +1 | K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co., Ltd. | 2018 | — |
| +2 | K210021 | Axon Therapy | Neuralace Medical, Inc. | 2021 | — |
| +3 | K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100… | Tonica Elektronik A/S | 2023 | — |
| +3 | K233364 | Axon Therapy | Neuralace Medical, Inc. | 2024 | — |
| +4 | K250309 | BTL-199 | BTL Industries, Inc. | 2025 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K093138 | MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003Summary page 2…nzhen Dongdixin Technology Co., Ltd Legally MT9000 Series Electro-Stimulator Marketed Device 510 (K) Number K093138 There are basically the same between the FDES1 01 (ED4O1) Series Electro-Stimulator and the predicate device which wo… | 2010 |
What descends from it? (8)
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 13 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K181688 (Shenzhen Roundwhale Technology Co., Ltd., 2018) has gone furthest, with 6 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. 2012, 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?
FDESIOI(ED4OI) TENS and EMS 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 calf muscles to prevent venous thrombosis FDESIO2(ED402) TENS…
Read the full statement (126 words)
FDESIOI(ED4OI) TENS and EMS 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 calf muscles to prevent venous thrombosis
FDESIO2(ED402) TENS Stimulator
1. Symptomatic relief of chronic intractable pain
2. Post traumatic pain
3. Post surgical pain
FDESIO3(ED403) EMS Stimulator
1. Relaxation of muscle spasm.
2. Increase of 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 calf muscles to prevent venous thrombosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113010: FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113010
Report an extraction error
Are you the manufacturer?
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