Biowave Corporation: FDA clearances and approvals
Biowave Corporation has 8 FDA 510(k) clearances (first 2005, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time: 111 days. Since 2017 its median was 80 days, against 131 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 29 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 129 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 144 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 27 |
Review time against the same product codes
Since 2017, Biowave Corporation's cleared 510(k)s took a median 80 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 4 | 4 |
| GXY | Electrode, Cutaneous | 2 | 2 |
| LIH | Interferential Current Therapy | 1 | 1 |
| NHI | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | 1 | 1 |
Review panels
- Neurology (8)
Most recent Biowave Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261522 | BioWave BioWraps | GXY | 2026-06-03 | 27 |
| K203158 | BioWave BioWraps | GXY | 2021-07-08 | 259 |
| K210202 | BioWaveGO RX | GZJ | 2021-02-24 | 30 |
| K180943 | BioWaveGO | GZJ | 2018-08-17 | 129 |
| K152437 | BiowaveHOME Neuromodulation Pain Therapy Device | GZJ | 2015-09-25 | 29 |
| K072123 | HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE | GZJ | 2008-02-01 | 183 |
| K061166 | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM | NHI | 2006-08-15 | 110 |
| K052289 | DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE | LIH | 2005-12-13 | 112 |
Recalls
openFDA lists no recalls under a recalling firm named Biowave Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Biowave Corporation is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05511181: BioWave High-frequency Neurostimulation Versus TENS for the Treatment of Chronic Low Back Pain (Completed, started 2022-08-15)
Frequently asked questions
How many FDA 510(k) clearances does Biowave Corporation have?
Biowave Corporation has 8 FDA 510(k) clearances (first 2005, latest 2026), across 4 product codes in 1 review panel.
How long does FDA take to clear Biowave Corporation's 510(k)s?
The median time from FDA receipt to decision across Biowave Corporation's cleared 510(k)s is 111 days. Since 2017: 80 days, versus 131 days for all cleared 510(k)s in the same product codes.
What devices does Biowave Corporation make?
Its most frequent FDA product codes are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 4); GXY (Electrode, Cutaneous, 2); LIH (Interferential Current Therapy, 1).
Has Biowave Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Biowave Corporation. Related entities may recall under other names.
Next steps
- See all 8 Biowave Corporation clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Biowave Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.