FDA device listing

Pratiko Handrim for manual wheelchair

FDA device listing 1125688887 · PRATIKO MEDICAL INC.

Key facts

Proprietary names Pratiko Handrim for manual wheelchair
Owner/operator PRATIKO MEDICAL INC.
Owner/operator number 10055624
Product codes IMO
Device names IMO - Handrim, Wheelchair
Device class Class I
Classification regulations (21 CFR) 890.3920
Review panels Physical Medicine
Registered establishments PRATIKO MEDICAL INC.
Establishment registrations 3013829459
FEI numbers 3013829459
Establishment operations Manufacturer, Repackager/Relabeler
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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