FDA device listing

R3500,Stim3

FDA device listing 1604285323 · PAIN MANAGEMENT TECHNOLOGIES

Key facts

Proprietary names R3500,Stim3
Owner/operator PAIN MANAGEMENT TECHNOLOGIES
Owner/operator number 9002150
Premarket submissions K024036
Product codes IPF, LIH
Device names IPF - Stimulator, Muscle, Powered, LIH - Interferential Current Therapy
Device class Class II
Classification regulations (21 CFR) 882.5890, 890.5850
Review panels Neurology, Physical Medicine
Registered establishments PAIN MANAGEMENT TECHNOLOGIES
Establishment registrations 1528161
FEI numbers 1000122747
Establishment operations Complaint File Establishment
Registration valid through 2026

At a glance

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