Home / 510(k) Clearances / K243339

510(k) K243339

WiTOF by Idmed — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2025
Date Received
October 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Peripheral, Electric
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type

Other clearances by Idmed

  • K243562 — CuffGuard (August 12, 2025)
  • K172690 — ToFscan (May 31, 2018)

Other clearances for product code KOI

  • K250887 — Neuromuscular Transmission Monitor TOF3D (2510091) (October 21, 2025)
  • K242525 — iTOF® (December 5, 2024)
  • K220530 — Tetragraph Neuromuscular Transmission Monitor (August 17, 2022)
  • K220976 — Life Scope PT BSM-1700 Series Bedside Monitor (July 21, 2022)
  • K212434 — Neuromuscular Transmission Monitor TOF3D (May 5, 2022)
  • K213316 — Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM (December 29, 2021)
  • K201949 — Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scop (May 2, 2021)
  • K192958 — TwitchView System (April 2, 2020)
  • K190795 — Tetragraph Neuromuscular Transmission Monitor (October 18, 2019)
  • K172690 — ToFscan (May 31, 2018)