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510(k) K210572

Neurodyn V2.0, Neurodyn Aussie V2.0 by Ibramed Equipamentos Medicos — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2021
Date Received
February 26, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Ibramed Equipamentos Medicos

  • 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)
  • K121369 — NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR (December 19, 2012)

Other clearances for product code IPF

  • K251083 — Compact II (September 12, 2025)
  • K241433 — EVE Synergy (EVE-20M) (June 4, 2025)
  • K241488 — TrainFES Advance (February 5, 2025)
  • K240348 — Quantum Mitohormesis (QMT) (M2101) (December 19, 2024)
  • K240992 — eMVFit (MVF-10M) (October 10, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K233926 — accufit (March 21, 2024)
  • K233485 — M-Wave (January 26, 2024)