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510(k) K210202

BioWaveGO RX by Biowave Corporation — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2021
Date Received
January 25, 2021
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

  • K203158 — BioWave BioWraps (July 8, 2021)
  • K180943 — BioWaveGO (August 17, 2018)
  • 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)

Other clearances for product code GZJ

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  • K241228 — TENSWave (August 27, 2024)
  • K233046 — Electrical Neuromuscular Stimulator, Cure Trio (April 19, 2024)
  • K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (January 24, 2023)
  • K212618 — iRelieve Microcurrent Pain Relief System (September 14, 2022)
  • K213802 — StimOnTM Pain Relief System (GM2439) (August 26, 2022)
  • K220578 — Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (May 25, 2022)
  • K220503 — TENS device-EmeTerm 2, Model: YF-ZTY-E2 (April 23, 2022)