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
K780184Substantially Equivalent

Wheelchair Accessories

Orthopedic Equipment Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780184 is the FDA 510(k) clearance record for WHEELCHAIR ACCESSORIES, a class I device, cleared for Orthopedic Equipment Co., Inc. on under FDA product code IMX (Board, Lap, Wheelchair). FDA records list 45 510(k) clearances for Orthopedic Equipment Co., Inc., from to . As of , FDA records show no recalls naming K780184.

Clearance record

Decision date
Received
(10 days to decision)
Product code
IMX Board, Lap, Wheelchair
Regulation
21 CFR 890.3910
Device class
Class I
Review panel
Physical Medicine
Applicant
Orthopedic Equipment Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IMX

Trailing 12 months

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

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