510(k) · Cleared
ClearedH Wave Muscle Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electronic Waveform Laboratory, Inc. · IPF Stimulator, Muscle, Powered
Cleared on May 8, 1992 after a 170-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 8, 1992
- Review
- 170 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK915230 H Wave Muscle StimulatorElectronic Waveform Laboratory, Inc. · 1992
- Descendant · cites it directly · 3 of its ownK103738 H-WAVEElectronic Waveform Laboratory, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK112485 H-WAVEElectronic Waveform Lab, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK081998 H-Wave SportElectronic Waveform Laboratory, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK131910 MPPMarc Pro · 2014
- Descendant · 2 generations on · 0 of its ownK160255 HBOTC Muscle and Nerve StimulatorHb Medical, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K103738H-WAVEElectronic Waveform Laboratory, Inc. · 2011 · cites it directly3descendants
- K112485H-WAVEElectronic Waveform Lab, Inc. · 2011 · 2 generations on2descendants
- K081998H-Wave SportElectronic Waveform Laboratory, Inc. · 2009 · cites it directly2descendants
- K131910MPPMarc Pro · 2014 · 2 generations on1descendant
- K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915230 | H Wave Muscle Stimulator | Electronic Waveform Laboratory, Inc. | 1992 | — |
| +1 | K103738 | H-WAVE | Electronic Waveform Laboratory, Inc. | 2011 | — |
| +2 | K112485 | H-WAVE | Electronic Waveform Lab, Inc. | 2011 | — |
| +1 | K081998 | H-Wave Sport | Electronic Waveform Laboratory, Inc. | 2009 | — |
| +2 | K131910 | MPP | Marc Pro | 2014 | — |
| +2 | K160255 | HBOTC Muscle and Nerve Stimulator | Hb Medical, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K103738 (Electronic Waveform Laboratory, Inc., 2011) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K915230 · printed Nov 5, 2026
Cite this page
510(k) Report. “K915230: H Wave Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K915230
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026