Biowave Corporation
FDA Regulatory Profile
Biowave Corporation has 0 FDA recalls, 6 inspections, 8 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- May 26, 2026 · VAI
- Latest 510(k)
- Jun 3, 2026
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 8 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 6 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| May 26, 2026 | Westport, CT | Devices | Voluntary Action Indicated (VAI) | 3004558433 |
| Jun 21, 2023 | Westport, CT | Devices | Voluntary Action Indicated (VAI) | 3004558433 |
| Apr 27, 2017 | Westport, CT | Devices | No Action Indicated (NAI) | 3004558433 |
| Aug 28, 2013 | Westport, CT | Devices | No Action Indicated (NAI) | 3004558433 |
| Feb 18, 2011 | Westport, CT | Devices | No Action Indicated (NAI) | 3004558433 |
| Jul 28, 2010 | Westport, CT | Devices | Voluntary Action Indicated (VAI) | 3004558433 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3004558433 | Westport, CT | 6 | May 26, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261522 | BioWave BioWraps | Jun 3, 2026 |
| K203158 | BioWave BioWraps | Jul 8, 2021 |
| K210202 | BioWaveGO RX | Feb 24, 2021 |
| K180943 | BioWaveGO | Aug 17, 2018 |
| K152437 | BiowaveHOME Neuromodulation Pain Therapy Device | Sep 25, 2015 |
| K072123 | HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE | Feb 1, 2008 |
| K061166 | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM | Aug 15, 2006 |
| K052289 | DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE | Dec 13, 2005 |