510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821404Substantially Equivalent

Light Weight Aluminum Walker

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

K821404 is the FDA 510(k) clearance record for LIGHT WEIGHT ALUMINUM WALKER, a class I device, cleared for Manuco Manufacturing Co., Inc. on under FDA product code ITJ (Walker, Mechanical). FDA records list 4 510(k) clearances for Manuco Manufacturing Co., Inc., from to . As of , FDA records show no recalls naming K821404.

Clearance record

Decision date
Received
(10 days to decision)
Product code
ITJ Walker, Mechanical
Regulation
21 CFR 890.3825
Device class
Class I
Review panel
Physical Medicine
Applicant
Manuco Manufacturing Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ITJ

Trailing 12 months

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

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