FDA device listing

Game Ready Therapy System

FDA device listing 1871949408 · PRIDE Industries

Key facts

Proprietary names Game Ready Therapy System
Owner/operator PRIDE Industries
Owner/operator number 10042055
Product codes ILO, IRP
Device names ILO - Pack, Hot Or Cold, Water Circulating, IRP - Massager, Powered Inflatable Tube
Device class Class II
Classification regulations (21 CFR) 890.5650, 890.5720
Review panels Physical Medicine
Registered establishments PRIDE Industries
Establishment registrations 3008570882
FEI numbers 2937446
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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