FDA device listing

Adjustable Height Bath Seat,Ashby Easy Fit 4 Raised Toilet Seat,Derby Half Step,Homecraft Atlantic Commode and Shower…

FDA device listing 1776350357 · Performance Health Supply

Key facts

Proprietary names Adjustable Height Bath Seat,Ashby Easy Fit 4 Raised Toilet Seat,Derby Half Step,Homecraft Atlantic Commode and Shower Chair,Homecraft Corner Shower Stool,Homecraft Lightweight Cut-out Shower Chair,Homecraft Ocean Heavy Duty Shower Stool,Homecraft Ocean Wheeled Shower Commode Chair,Homecraft Raised Toilet Seat,Homecraft Round Shower Stool,Homecraft Savanah Raised Toilet Seat,Homecraft Savanah…
Owner/operator Performance Health Supply
Owner/operator number 10050734
Product codes ILS
Device names ILS - Adaptor, Hygiene
Device class Class I
Classification regulations (21 CFR) 890.5050
Review panels Physical Medicine
Registered establishments Performance Health Bingley, PERFORMANCE HEALTH INTERNATIONAL LTD, Performance Health Supply, Inc., PERFORMANCE HEALTH SUPPLY, LLC., TUMBLE FORMS, INC.
Establishment registrations 2128677, 2435707, 9681624, 3009542966, 3013473968
FEI numbers 2128677, 1000119616, 3002903298, 3009542966, 3013473968
Establishment operations Contract Manufacturer, Foreign Exporter, Specification Developer, 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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