Biowave Corporation

FDA Regulatory Profile

Biowave Corporation appears in FDA public data with 0 recalls, 8 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 3, 2026.

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
6
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K261522BioWave BioWrapsJune 3, 2026
K203158BioWave BioWrapsJuly 8, 2021
K210202BioWaveGO RXFebruary 24, 2021
K180943BioWaveGOAugust 17, 2018
K152437BiowaveHOME Neuromodulation Pain Therapy DeviceSeptember 25, 2015
K072123HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICEFebruary 1, 2008
K061166DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEMAugust 15, 2006
K052289DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICEDecember 13, 2005