FDA device listing

Magstim 200²

FDA device listing 1019690077 · The Magstim Company Ltd.

Key facts

Proprietary names Magstim 200²
Owner/operator The Magstim Company Ltd.
Owner/operator number 8021774
Premarket submissions K060847
Product codes GWF, JXE
Device names GWF - Stimulator, Electrical, Evoked Response, JXE - Device, Nerve Conduction Velocity Measurement
Device class Class II
Classification regulations (21 CFR) 882.1550, 882.1870
Review panels Neurology
Registered establishments THE MAGSTIM COMPANY LTD.
Establishment registrations 8021774
FEI numbers 3002808356
Establishment operations Complaint File Establishment, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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