FDA device listing

Splint, Extremity, Inflatable, External

FDA device listing 1791772020 · TAIWAN STANCH CO., LTD.

Key facts

Owner/operator TAIWAN STANCH CO., LTD.
Owner/operator number 9026133
Product codes FZF
Device names FZF - Splint, Extremity, Inflatable, External
Device class Class I
Classification regulations (21 CFR) 878.3900
Review panels General & Plastic Surgery
Registered establishments R&R Medical Corporation Ltd.
Establishment registrations 3010409218
FEI numbers 3010409218
Establishment operations 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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