510(k) · Cleared
ClearedH-WAVE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electronic Waveform Lab, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Dec 6, 2011 as substantially equivalent to K813601 (Electronic Waveform Laboratory, Inc., 1982) and 2 other predicates after a 99-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Dec 6, 2011
- Review
- 99 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K915230 (1992). 4 ancestors in all, the oldest K813601 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK915230 H Wave Muscle StimulatorElectronic Waveform Laboratory, Inc. · 1992
- 1 generation backK103738 H-WAVEElectronic Waveform Laboratory, Inc. · 2011
- This deviceK112485 H-WAVEElectronic Waveform Lab, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK131910 MPPMarc Pro · 2014
- Descendant · cites it directly · 0 of its ownK160255 HBOTC Muscle and Nerve StimulatorHb Medical, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915230 | H Wave Muscle Stimulator | Electronic Waveform Laboratory, Inc. | 1992 | — |
| −1 | K103738 | H-WAVE | Electronic Waveform Laboratory, Inc. | 2011 | — |
| 0 (this device) | K112485 | H-WAVE | Electronic Waveform Lab, Inc. | 2011 | — |
| +1 | K131910 | MPP | Marc Pro | 2014 | — |
| +1 | K160255 | HBOTC Muscle and Nerve Stimulator | Hb Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K813601 | E.W.L. P-Tens Model (TensSummary page 1…eous Electrical Nerve Stimulator for Pain Relief 21 C.F.R. § 882.5890 (Product Code GZJ) Predicate Devices Model P, Electronic Waveform Lab, Inc. (K813601) Model H-Wave® H4, Electronic Waveform Lab, Inc. (K1 03738) Model HMS DHR-3, Home Medical Services, Inc. (K… | 1982 |
| * | K103738 | H-WAVESummary page 1…§ 882.5890 (Product Code GZJ) Predicate Devices Model P, Electronic Waveform Lab, Inc. (K813601) Model H-Wave® H4, Electronic Waveform Lab, Inc. (K1 03738) Model HMS DHR-3, Home Medical Services, Inc. (K021496) Intended Use ( Indications for Use The H-Wave H4 is… | 2011 |
| * | K021496 | HMS-DHR-3 Neuromuscular StimulatorSummary page 1…P, Electronic Waveform Lab, Inc. (K813601) Model H-Wave® H4, Electronic Waveform Lab, Inc. (K1 03738) Model HMS DHR-3, Home Medical Services, Inc. (K021496) Intended Use ( Indications for Use The H-Wave H4 is indicated for the treatment of chronic pain, acute pain, post-… | 2002 |
What descends from it? (2)
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?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 19.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K131910 (Marc Pro, 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The H-Wave® H-4 is indicated for the treatment of chronic pain, acute pain, post-surgical pain, and temporary pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112485: H-WAVE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112485
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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