FDA device listing

Drive,Guardian,Mckesson Corp./Cypress Medical Products,Medline,Medline Industries, Inc.,TECH-MED SERVICES INC.

FDA device listing 1083038131 · TAIWAN AN I CO.,LTD.

Key facts

Proprietary names Drive,Guardian,Mckesson Corp./Cypress Medical Products,Medline,Medline Industries, Inc.,TECH-MED SERVICES INC.
Owner/operator TAIWAN AN I CO.,LTD.
Owner/operator number 9021165
Product codes IPR
Device names IPR - Crutch
Device class Class I
Classification regulations (21 CFR) 890.3150
Review panels Physical Medicine
Registered establishments A & I INDUSTRIES LTD, CC HSING COMPANY LIMITED
Establishment registrations 3004034546, 3014273557
FEI numbers 3004034546, 3014273557
Establishment operations Foreign Exporter, 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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