510(k) · Cleared
ClearedCombo Electrotherapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Roundwhale Technology Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Nov 1, 2019 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Nov 1, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK192087 Combo Electrotherapy DeviceShenzhen Roundwhale Technology Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK231423 Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F…Shenzhen Roundwhale Technology Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K231423Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100…Shenzhen Roundwhale Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K192087 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co., Ltd. | 2019 | — |
| +1 | K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100… | Shenzhen Roundwhale Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUH? 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 NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100… | 2024 | 0 |
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?
- Of its descendants, K231423 (Shenzhen Roundwhale Technology Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, 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 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
Over-The-Counter Use: TENS mode:: It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. EMS mode: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. Prescription Use: For TENS mode: 1) Symptomatic relief of chronic…
Read the full statement (124 words)
Over-The-Counter Use:
TENS mode::
It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS mode:
This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
Prescription Use:
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192087 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192087: Combo Electrotherapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192087
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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