510(k) · Cleared
ClearedTENS and EMS Stimulator, TENS Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astek Technology, Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Jan 11, 2020 as substantially equivalent to K113010 (Famidoc Technology Co., Ltd., 2012) after a 432-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jan 11, 2020
- Review
- 432 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K984142 (1999). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- 3 generations backK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
- 2 generations backK093138 MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001…Shenzhen Dongdixin Technology Co., Ltd. · 2010 · Recalled
- 1 generation backK113010 FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd. · 2012
- This deviceK183074 TENS and EMS Stimulator, TENS StimulatorAstek Technology, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| −3 | 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 | K113010 | FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator | Famidoc Technology Co., Ltd. | 2012 | — |
| 0 (this device) | K183074 | TENS and EMS Stimulator, TENS Stimulator | Astek Technology, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (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 |
|---|---|---|---|
| * | K113010 | FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorSummary page 4…evice Class: II Primary Product Code IPF Subsequent Product Code GZJ 5.5 Identification of the Predicate Device (K113010) Predicate Device Name: FDES 101 (ED401) TENS and EMS Stimulator, FDES 10… | 2012 |
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 21 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K113010.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
TENS Stimulator (Model no.: AK-10M) TENS Stimulator provides 5 types TENS output modes (P1-P5) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain TENS and EMS Stimulator (Model no.: AK3-20 and AK3-25) TENS and EMS Stimulator provides 8 types output modes (P1-P8). TENS/EMS output modes (P1-P6&P8) and TENS output modes (P7) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2)…
Read the full statement (203 words)
TENS Stimulator (Model no.: AK-10M)
TENS Stimulator provides 5 types TENS output modes (P1-P5)
For TENS mode
(1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain
TENS and EMS Stimulator (Model no.: AK3-20 and AK3-25)
TENS and EMS Stimulator provides 8 types output modes (P1-P8). TENS/EMS output modes (P1-P6&P8) and TENS output modes (P7)
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
TENS and EMS Stimulator (Model no.: AK3-50)
TENS and EMS Stimulator provides 10 types output modes (P0-P9). TENS output modes (P0-P4) and EMS output modes (P5-P9)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183074: TENS and EMS Stimulator, TENS Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183074
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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