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510(k) K233485

M-Wave by Zynex Medical, Inc. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2024
Date Received
October 27, 2023
Clearance Type
Abbreviated
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 Zynex Medical, Inc.

  • K223217 — Zynex Monitoring System, Model CM-1600 (June 16, 2023)
  • K191697 — Cardiac Monitor 1500 (February 21, 2020)
  • K121820 — INWAVE (August 24, 2012)
  • K111279 — NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM (September 20, 2011)

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)
  • K232937 — BTL-899M (December 26, 2023)