510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834344Substantially Equivalent

Med-Opedic Sleep System

Bemco Mattress Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834344 is the FDA 510(k) clearance record for MED-OPEDIC SLEEP SYSTEM, a class II device, cleared for Bemco Mattress Co. on under FDA product code INX (Bed, Air Fluidized). FDA records list one 510(k) clearance for Bemco Mattress Co. As of , FDA records show no recalls naming K834344.

Clearance record

Decision date
Received
(36 days to decision)
Product code
INX Bed, Air Fluidized
Regulation
21 CFR 890.5160
Device class
Class II
Review panel
Physical Medicine
Applicant
Bemco Mattress Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code INX

Trailing 12 months

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

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