Data / Medical devices / Mattress, Flotation Therapy, Non-Powered

Mattress, Flotation Therapy, Non-Powered (IKY): 139 FDA-registered makers in 20 countries

139 establishments in 20 countries are registered with the FDA to make Mattress, Flotation Therapy, Non-Powered (product code IKY, Class 1, 21 CFR 880.5150). 0 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on March 12, 1992, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

IKY

Device class

1

Regulation

880.5150

Medical specialty

General Hospital

Makers by country

Makers of Mattress, Flotation Therapy, Non-Powered

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated March 12, 1992. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.