510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K932396Substantially Equivalent

Peri-Comfort(tm) Seating Cushion

Chi'Am Intl., Circle Pines MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932396 is the FDA 510(k) clearance record for PERI-COMFORT(TM) SEATING CUSHION, cleared for Chi'Am Intl. on under FDA product code LRL (Cushion, Hemorrhoid). FDA records list one 510(k) clearance for Chi'Am Intl. As of , FDA records show no recalls naming K932396.

Clearance record

Decision date
Received
(135 days to decision)
Product code
LRL Cushion, Hemorrhoid
Device class
Unclassified
Review panel
Unknown
Applicant
Chi'Am Intl. P.O. Box 445, Circle Pines MN
510(k) summary
Statement
Third party review
No

Clearances, product code LRL

Trailing 12 months

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

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