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510(k) K180943

BioWaveGO by Biowave Corporation — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2018
Date Received
April 10, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Biowave Corporation

  • K203158 — BioWave BioWraps (July 8, 2021)
  • K210202 — BioWaveGO RX (February 24, 2021)
  • K152437 — BiowaveHOME Neuromodulation Pain Therapy Device (September 25, 2015)
  • K072123 — HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE (February 1, 2008)
  • K061166 — DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM (August 15, 2006)
  • K052289 — DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE (December 13, 2005)

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