FDA device listing

Mechanical Wheelchair

FDA device listing 1970526073 · Shin-I Medical Manufacturing Co. Ltd.

Key facts

Proprietary names Mechanical Wheelchair
Owner/operator Shin-I Medical Manufacturing Co. Ltd.
Owner/operator number 10048609
Product codes IOR
Device names IOR - Wheelchair, Mechanical
Device class Class I
Classification regulations (21 CFR) 890.3850
Review panels Physical Medicine
Registered establishments Shin-I Medical Manufacturing Co. Ltd.
Establishment registrations 1000252066
FEI numbers 1000252066
Establishment operations Contract 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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