Home New England Westport, CT BioWave COMPANY
FDA-cleared device company
BioWave is a Medtech company. From company website Source · Oct 12, 2026
Keywords: medtech Chronic Pain Lumbar Pain Syndrome Low Back Pain
Profile checked Oct 10, 2026
At a glance HQ Westport, CT source Region New England Stage FDA-cleared device company Latest trial Not phased (device or behavioral study): BioWave High-frequency Neurostimulation Versus TENS for the Treatment of Chronic Low Back Pain (Aug 15, 2022) source Timeline Jun 3, 2026 FDA FDA 510(k) clearance: BioWave BioWraps — K261522, Jun 3, 2026. Applicant at approval: Biowave Corporation. source ↗ Aug 15, 2022 Trial start Not phased (device or behavioral study): BioWave High-frequency Neurostimulation Versus TENS for the Treatment of Chronic Low Back Pain source ↗ Clinical trials (lead sponsor) 1 Record Title Phase Status Start Primary completion NCT05511181 BioWave High-frequency Neurostimulation Versus TENS for the Treatment of Chronic Low Back Pain Not phased (device or behavioral study) Completed Aug 15, 2022 Apr 12, 2023 (actual)
FDA records (last 2 years) Jun 3, 2026 FDA 510(k) clearance: BioWave BioWraps — K261522, Jun 3, 2026. Applicant at approval: Biowave Corporation. source ↗ 