510(k) · Cleared
ClearedR-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Roundwhale Technology Co., Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Sep 7, 2018 as substantially equivalent to K113010 (Famidoc Technology Co., Ltd., 2012) after a 73-day review. Its family tree reaches back 4 generations to 1999. 6 later devices descend from it.
- Decided
- Sep 7, 2018
- Review
- 73 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. 6 later devices descend from it, 1 citing it directly.
- 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 deviceK181688 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS…Shenzhen Roundwhale Technology Co., Ltd. · 2018
- Descendant · cites it directly · 5 of its ownK210021 Axon TherapyNeuralace Medical, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK230014 MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption…Tonica Elektronik A/S · 2023
- Descendant · 2 generations on · 1 of its ownK233364 Axon TherapyNeuralace Medical, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK250309 BTL-199BTL Industries, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK250286 Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2…The Magstim Company Limited · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K210021Axon TherapyNeuralace Medical, Inc. · 2021 · cites it directly5descendants
- K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…Tonica Elektronik A/S · 2023 · 2 generations on3descendants
- K233364Axon TherapyNeuralace Medical, Inc. · 2024 · 2 generations on1descendant
- K250309BTL-199BTL Industries, Inc. · 2025 · 3 generations on0descendants
- K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2…The Magstim Company Limited · 2025 · 3 generations on0descendants
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) | K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co., Ltd. | 2018 | — |
| +1 | K210021 | Axon Therapy | Neuralace Medical, Inc. | 2021 | — |
| +2 | K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100… | Tonica Elektronik A/S | 2023 | — |
| +2 | K233364 | Axon Therapy | Neuralace Medical, Inc. | 2024 | — |
| +3 | K250309 | BTL-199 | BTL Industries, Inc. | 2025 | — |
| +3 | K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim… | The Magstim Company Limited | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K113010 | FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorSummary page 6…102(ED402), Legally Marketed Device FDES103(ED403) 510 (K) Number K113010 4. Description of Device The RW Series A Electrical Stimulator, which includes models R-C1, R-E1 and R-T1, are Transcuta… | 2012 |
| † | K070612 | Top-Rank Adhesive Electrode | 2007 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210021 | Axon Therapy | 2021 | 5 |
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 19 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K210021 (Neuralace Medical, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 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. 2018, 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?
R-C1 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. R-E1 EMS Stimulator 1.…
Read the full statement (127 words)
R-C1 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.
R-E1 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 calf muscles to prevent venous thrombosis.
R-T1 TENS Stimulator
1. Symptomatic relief of chronic intractable pain;
2. Post traumatic pain;
3. Post surgical pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181688: R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 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/K181688
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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