FDA device listing

ORTHOSIS CERVICAL COLLAR

FDA device listing 1127849882 · Zhejiang Rehan Medical Manufacturing Co., Ltd.

Key facts

Proprietary names ORTHOSIS CERVICAL COLLAR
Owner/operator Zhejiang Rehan Medical Manufacturing Co., Ltd.
Owner/operator number 10031086
Product codes IQK
Device names IQK - Orthosis, Cervical
Device class Class I
Classification regulations (21 CFR) 890.3490
Review panels Physical Medicine
Registered establishments Zhejiang Rehan Medical Manufacturing Co., Ltd.
Establishment registrations 3008114969
FEI numbers 3008114969
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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