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510(k) K233098

MYOTouch Muscle Stimulator by Sunmed, LLC — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2024
Date Received
September 26, 2023
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 Sunmed, LLC

  • K121743 — EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN (March 28, 2013)
  • K081805 — CUFFALERT (November 14, 2008)
  • K062112 — SUNMED FOLEY CATHETERS (June 4, 2007)
  • K955631 — ORTHOPLUG HARD BONE DESIGN (February 27, 1996)
  • K955632 — ORTHOPLUG SOFT BONE DESIGN (February 27, 1996)
  • K921263 — SUNLITE LARYNGOSCOPE (June 1, 1993)

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