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510(k) K121369

NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR by Ibramed Equipamentos Medicos — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2012
Date Received
May 7, 2012
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 Ibramed Equipamentos Medicos

  • K210572 — Neurodyn V2.0, Neurodyn Aussie V2.0 (May 11, 2021)
  • K131926 — THERMOPULSE (July 24, 2014)
  • K131917 — NEURODYN COMPACT, NEURODYN II (April 29, 2014)
  • K131309 — SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ (January 27, 2014)
  • K131629 — NEURODYN MULTIWAVE, AUSSIE SPORT (November 26, 2013)

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  • 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)