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

8
Total
8
Cleared
0
Denied

FDA 510(k) Regulatory Record - Biowave Corporation Neurology ✕

8 devices
1-8 of 8
Cleared Jun 03, 2026
BioWave BioWraps
K261522 · GXY
Neurology · 27d
Cleared Jul 08, 2021
BioWave BioWraps
K203158 · GXY
Neurology · 259d
Cleared Feb 24, 2021
BioWaveGO RX
K210202 · GZJ
Neurology · 30d
Cleared Aug 17, 2018
BioWaveGO
K180943 · GZJ
Neurology · 129d
Cleared Sep 25, 2015
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
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