FDA device listing

Bath Seat

FDA device listing 1498005012 · OPTIMAL MEDICAL CO., LTD.

Key facts

Proprietary names Bath Seat
Owner/operator OPTIMAL MEDICAL CO., LTD.
Owner/operator number 10034278
Product codes ILS
Device names ILS - Adaptor, Hygiene
Device class Class I
Classification regulations (21 CFR) 890.5050
Review panels Physical Medicine
Registered establishments OPTIMAL MEDICAL CO., LTD.
Establishment registrations 3006199389
FEI numbers 3006199389
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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