FDA device listing

Thermoskin,Trioxon

FDA device listing 1658536515 · United Pacific Industries PTY. Ltd.

Key facts

Proprietary names Thermoskin,Trioxon
Owner/operator United Pacific Industries PTY. Ltd.
Owner/operator number 10022995
Product codes ITQ
Device names ITQ - Joint, Knee, External Brace
Device class Class I
Classification regulations (21 CFR) 890.3475
Review panels Physical Medicine
Registered establishments UNITED PACIFIC INDUSTRIES PTY. LTD.
Establishment registrations 8043954
FEI numbers 3003089166
Establishment operations Contract Manufacturer, Manufacturer, Repackager/Relabeler, Specification Developer
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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