FDA device listing

HANDRIM, WHEELCHAIR

FDA device listing 1951474170 · MERITS HEALTH PRODUCTS CO., LTD.

Key facts

Proprietary names HANDRIM, WHEELCHAIR
Owner/operator MERITS HEALTH PRODUCTS CO., LTD.
Owner/operator number 9008298
Product codes IMO
Device names IMO - Handrim, Wheelchair
Device class Class I
Classification regulations (21 CFR) 890.3920
Review panels Physical Medicine
Registered establishments MERITS HEALTH PRODUCTS CO., LTD.
Establishment registrations 9680333
FEI numbers 1000334118
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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