FDA device listing

Pelvic girdle

FDA device listing 1986978161 · DONGGUAN REDTHERA TECHNOLOGY CO., LTD.

Key facts

Proprietary names Pelvic girdle
Owner/operator DONGGUAN REDTHERA TECHNOLOGY CO., LTD.
Owner/operator number 10092594
Product codes IPY
Device names IPY - Orthosis, Lumbo-Sacral
Device class Class I
Classification regulations (21 CFR) 890.3490
Review panels Physical Medicine
Registered establishments DONGGUAN REDTHERA TECHNOLOGY CO., LTD.
Establishment registrations 3035878914
FEI numbers 3035878914
Establishment operations Foreign Exporter, 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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