FDA device listing

Norco Multi Use Electrode

FDA device listing 1744548742 · NORTH COAST MEDICAL, INC.

Key facts

Proprietary names Norco Multi Use Electrode
Owner/operator NORTH COAST MEDICAL, INC.
Owner/operator number 9000531
Premarket submissions K130987
Product codes GXY
Device names GXY - Electrode, Cutaneous
Device class Class II
Classification regulations (21 CFR) 882.1320
Review panels Neurology
Registered establishments NORTH COAST MEDICAL, INC.
Establishment registrations 2939821
FEI numbers 1000124207
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 100–999 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

Browse all FDA device listings