510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813356Substantially Equivalent

Device for Repositioning a Bet Patient

Ali-Oop Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813356 is the FDA 510(k) clearance record for DEVICE FOR REPOSITIONING A BET PATIENT, a class I device, cleared for Ali-Oop Co., Inc. on under FDA product code FNJ (Bed, Manual). FDA records list one 510(k) clearance for Ali-Oop Co., Inc. As of , FDA records show no recalls naming K813356.

Clearance record

Decision date
Received
(75 days to decision)
Product code
FNJ Bed, Manual
Regulation
21 CFR 880.5120
Device class
Class I
Review panel
General Hospital
Applicant
Ali-Oop Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FNJ

Trailing 12 months

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

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