FDA device listing

Platform,Walker tips

FDA device listing 1422356124 · Genteel Homecare Products Co., Ltd

Key facts

Proprietary names Platform,Walker tips
Owner/operator Genteel Homecare Products Co., Ltd
Owner/operator number 10045635
Product codes INP
Device names INP - Tips And Pads, Cane, Crutch And Walker
Device class Class I
Classification regulations (21 CFR) 890.3790
Review panels Physical Medicine
Registered establishments GENTEEL HOMECARE PRODUCTS CO., LTD.
Establishment registrations 3006206434
FEI numbers 3006206434
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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