FDA device listing

Iomed

FDA device listing 1357972726 · DJO, LLC

Key facts

Proprietary names Iomed
Owner/operator DJO, LLC
Owner/operator number 9015378
Premarket submissions K932620
Product codes EGJ
Device names EGJ - Device, Iontophoresis, Other Uses
Device class Class II
Classification regulations (21 CFR) 890.5525
Review panels Physical Medicine
Registered establishments DJO, LLC
Establishment registrations 3017264244
FEI numbers 3017264244
Establishment operations Specification Developer
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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