Data / Medical devices / United States / Biowave Corporation
Biowave Corporation: FDA-registered device maker in Norwalk, CT, United States, 7 510(k) clearances
Biowave Corporation is registered with the FDA (registration 3004558433) in Norwalk, CT, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 8, 2021. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004558433
- Address
- 8 Knight St Ste 201, Norwalk, CT, United States, 06851
- Owner or operator
- BIOWAVE CORPORATION (9086399)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 10, 2007
- Registered through
- 2026
- Brand names listed
- BioWaveGO, BioWaveGO Rx, BioWaveHOME, BioWavePENS, BioWrap Electrode Garments
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Interferential Current Therapy | LIH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | NHI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 8, 2021 | K203158 | BioWave BioWraps | GXY | Substantially Equivalent | Biowave Corporation | accessdata.fda.gov |
| February 24, 2021 | K210202 | BioWaveGO RX | GZJ | Substantially Equivalent | Biowave Corporation | accessdata.fda.gov |
| August 17, 2018 | K180943 | BioWaveGO | GZJ | Substantially Equivalent | Biowave Corporation | accessdata.fda.gov |
| September 25, 2015 | K152437 | BiowaveHOME Neuromodulation Pain Therapy Device | GZJ | Substantially Equivalent | Biowave Corporation | accessdata.fda.gov |
| February 1, 2008 | K072123 | HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE | GZJ | Substantially Equivalent | Biowave Corporation | accessdata.fda.gov |
| August 15, 2006 | K061166 | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM | NHI | Substantially Equivalent | Biowave Corporation | accessdata.fda.gov |
| December 13, 2005 | K052289 | DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE | LIH | Substantially Equivalent | Biowave Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
- All makers of Interferential Current Therapy
Updated July 8, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.