510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K855181Substantially Equivalent

Comfortex Wheelchair Cushion

Comfortex, Inc., Winona MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855181 is the FDA 510(k) clearance record for COMFORTEX WHEELCHAIR CUSHION, a class I device, cleared for Comfortex, Inc. on under FDA product code KNN (Components, Wheelchair). FDA records list 4 510(k) clearances for Comfortex, Inc., from to . As of , FDA records show no recalls naming K855181.

Clearance record

Decision date
Received
(18 days to decision)
Product code
KNN Components, Wheelchair
Regulation
21 CFR 890.3920
Device class
Class I
Review panel
Physical Medicine
Applicant
Comfortex, Inc. 420 Main St., Winona MN
Third party review
No

Clearances, product code KNN

Trailing 12 months

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

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