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510(k) K152437

BiowaveHOME Neuromodulation Pain Therapy Device by Biowave Corporation — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2015
Date Received
August 27, 2015
Clearance Type
Special
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

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  • K210202 — BioWaveGO RX (February 24, 2021)
  • K180943 — BioWaveGO (August 17, 2018)
  • 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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