510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823816Substantially Equivalent

Wheelchair Patient Restraints

Danek Medical, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823816 is the FDA 510(k) clearance record for WHEELCHAIR PATIENT RESTRAINTS, a class I device, cleared for Danek Medical, Inc. on under FDA product code KNO (Accessories, Wheelchair). FDA records list 56 510(k) clearances for Danek Medical, Inc., from to . As of , FDA records show no recalls naming K823816.

Clearance record

Decision date
Received
(28 days to decision)
Product code
KNO Accessories, Wheelchair
Regulation
21 CFR 890.3910
Device class
Class I
Review panel
Physical Medicine
Applicant
Danek Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KNO

Trailing 12 months

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

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