FDA device listing

Knee brace 01, Knee brace 02, Knee brace 03

FDA device listing 1999391947 · Ningbo Skyey Industry & Trade Co.Ltd

Key facts

Proprietary names Knee brace 01, Knee brace 02, Knee brace 03
Owner/operator Ningbo Skyey Industry & Trade Co.Ltd
Owner/operator number 10087871
Product codes MRI
Device names MRI - Orthosis, Truncal/Orthosis, Limb
Device class Class I
Classification regulations (21 CFR) 890.3490
Review panels Physical Medicine
Registered establishments NINGBO SKYEY INDUSTRY & TRADE CO.LTD
Establishment registrations 3027507876
FEI numbers 3027507876
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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