510(k) · Cleared
ClearedLT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator
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 Jan 29, 2010 as substantially equivalent to K082514 (Medihightec Medical Co., Ltd., 2008) after a 14-day review. Its family tree reaches back 4 generations to 2001. 4 later devices descend from it.
- Decided
- Jan 29, 2010
- Review
- 14 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010782 (2001). 6 ancestors in all, the oldest K010665 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK010782 Transamerican TensTransamerica Medical Systems · 2001
- 3 generations backK020749 Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803…Everyway Medical Instruments Co.,Ltd · 2002
- 2 generations backK071951 Comfy Series: EV-804, EV-805 & EV-806Everyway Medical Instruments Co.,Ltd · 2007
- 1 generation backK082514 Tens/Ems Combo, Ems, TensMedihightec Medical Co., Ltd. · 2008
- This deviceK100117 LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems…Shenzhen Dongdixin Technology Co., Ltd. · 2010
- Descendant · cites it directly · 3 of its ownK102014 Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK133779 CP Relief WandMid-America Medical Innovations, LLC · 2014
- Descendant · 3 generations on · 0 of its ownK252236 CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK113544 Electronic Pulse Massager Tens Electronic Pulse MassagerProspera Corporation · 2012
Most influential descendants
Showing 4 of 4 · See all- K102014Tens Stimulator, Models 2800 and 3000Koalaty Products, Inc. · 2010 · cites it directly3descendants
- K133779CP Relief WandMid-America Medical Innovations, LLC · 2014 · 2 generations on1descendant
- K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025 · 3 generations on0descendants
- K113544Electronic Pulse Massager Tens Electronic Pulse MassagerProspera Corporation · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010782 | Transamerican Tens | Transamerica Medical Systems | 2001 | — |
| −3 | K020749 | Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens | Everyway Medical Instruments Co.,Ltd | 2002 | — |
| −2 | K071951 | Comfy Series: EV-804, EV-805 & EV-806 | Everyway Medical Instruments Co.,Ltd | 2007 | — |
| −1 | K082514 | Tens/Ems Combo, Ems, Tens | Medihightec Medical Co., Ltd. | 2008 | — |
| 0 (this device) | K100117 | LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | — |
| +1 | K102014 | Tens Stimulator, Models 2800 and 3000 | Koalaty Products, Inc. | 2010 | — |
| +2 | K133779 | CP Relief Wand | Mid-America Medical Innovations, LLC | 2014 | — |
| +3 | K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 2025 | — |
| +2 | K113544 | Electronic Pulse Massager Tens Electronic Pulse Massager | Prospera Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 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 19.6 · 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 |
|---|---|---|---|
| * | K082514 | Tens/Ems Combo, Ems, TensSummary page 2…GZJ Device Class- I 2. Predicate Device: Legally Marketed Device: TENS/EMS Combo, TENS, EMS 510(k)Number: K082514 Manufacturer: MEDIHIGHTEC MEDICAL CO., LTD 3. Description of Proposed Device: The LT3000 Series Stim… | 2008 |
| † | K070612 | Top-Rank Adhesive Electrode | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102014 | Tens Stimulator, Models 2800 and 3000 | 2010 | 3 |
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 9 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K102014 (Koalaty Products, Inc., 2010) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K082514.
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?
LT3000 Combo Stimulator 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain 2. Increase of blood flow in the treatment area 3. Relaxation of muscle spasm 4. Immediate post-surgical stimulation of muscles to prevent venous thrombosis 5. Prevention or retardation of disuse atrophy 6. Muscle re-education 7. Maintaining or increasing range of motion. LT3001 TENS Stimulator Symptomatic relief of chronic…
Read the full statement (122 words)
LT3000 Combo Stimulator
1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
2. Increase of blood flow in the treatment area
3. Relaxation of muscle spasm
4. Immediate post-surgical stimulation of muscles to prevent venous thrombosis
5. Prevention or retardation of disuse atrophy
6. Muscle re-education
7. Maintaining or increasing range of motion.
LT3001 TENS Stimulator
Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
LT3002 EMS Stimulator
1. Relaxation of muscle spasm.
2. Increase of blood flow in the treatment area
3. Immediate post-surgical stimulation of muscles to prevent venous thrombosis
4. Muscle re-education
5. Prevention or retardation of disuse atrophy
6. Maintaining or increasing range of motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100117: LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100117
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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