510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K922160Substantially Equivalent

Aquamotion by Ferno Ille Hydrotherapy Pools

Aquamotion, Inc., Berthoud CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922160 is the FDA 510(k) clearance record for AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS, a class II device, cleared for Aquamotion, Inc. on under FDA product code ILJ (Bath, Hydro-Massage). FDA records list one 510(k) clearance for Aquamotion, Inc. As of , FDA records show no recalls naming K922160.

Clearance record

Decision date
Received
(43 days to decision)
Product code
ILJ Bath, Hydro-Massage
Regulation
21 CFR 890.5100
Device class
Class II
Review panel
Physical Medicine
Applicant
Aquamotion, Inc. 110 Turner Ave., Berthoud CO
510(k) summary
Summary
Third party review
No

Clearances, product code ILJ

Trailing 12 months

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

FDA records show no clearances under product code ILJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ILJ, 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