510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K905126Substantially Equivalent

Comfort-Aire

Advanced Air Dynamics, Inc., Homestead FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905126 is the FDA 510(k) clearance record for COMFORT-AIRE, a class II device, cleared for Advanced Air Dynamics, Inc. on under FDA product code IOQ (Bed, Flotation Therapy, Powered). FDA records list one 510(k) clearance for Advanced Air Dynamics, Inc. As of , FDA records show no recalls naming K905126.

Clearance record

Decision date
Received
(35 days to decision)
Product code
IOQ Bed, Flotation Therapy, Powered
Regulation
21 CFR 890.5170
Device class
Class II
Review panel
Physical Medicine
Applicant
Advanced Air Dynamics, Inc. 27335 SW 166 Ave., Homestead FL
Third party review
No

Clearances, product code IOQ

Trailing 12 months

FDA records hold no clearances under product code IOQ in the trailing twelve months.

FDA records show no clearances under product code IOQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IOQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260