FDA device listing

Mattress, Flotation Therapy, Non-Powered

FDA device listing 1578688823 · Zikim Polymers Ind. 2001 Ltd.

Key facts

Owner/operator Zikim Polymers Ind. 2001 Ltd.
Owner/operator number 10080831
Product codes IKY
Device names IKY - Mattress, Flotation Therapy, Non-Powered
Device class Class I
Classification regulations (21 CFR) 880.5150
Review panels General Hospital
Registered establishments ZIKIM POLYMERS IND. 2001 LTD.
Establishment registrations 3018101346
FEI numbers 3018101346
Establishment operations 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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