Medical Device Manufacturer · US , North Attleboro , MA

Biowave Corporation - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2005

Recent clearances: BioWave BioWraps, BioWave BioWraps, BioWaveGO RX

Total

Cleared

Denied

Biowave Corporation has 8 FDA 510(k) cleared medical devices. Based in North Attleboro, US.

Latest FDA clearance: Jun 2026. Active since 2005. Primary specialty: Neurology.

Browse the FDA 510(k) cleared devices submitted by Biowave Corporation Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Mcra, LLC, Musculoskeletal Clinical Regulatory Advisers, LLC (Mcra) and MCRA, an IQVIA Business.

Biowave Corporation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Biowave Corporation

8 devices

1-8 of 8

BiowaveHOME Neuromodulation Pain Therapy Device

K152437 · GZJ

Neurology · 29d

Cleared Feb 01, 2008

HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE

K072123 · GZJ

Neurology · 183d

Cleared Aug 15, 2006

DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM

K061166 · NHI

Neurology · 110d

Cleared Dec 13, 2005

DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE

K052289 · LIH

Neurology · 112d

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Jun 08, 2026

Biowave Corporation - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Biowave Corporation

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