510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823811Substantially Equivalent

Overhead Arm Slings

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

K823811 is the FDA 510(k) clearance record for OVERHEAD ARM SLINGS, a class I device, cleared for Danek Medical, Inc. on under FDA product code ILE (Sling, Arm, Overhead Supported). FDA records list 56 510(k) clearances for Danek Medical, Inc., from to . As of , FDA records show no recalls naming K823811.

Clearance record

Decision date
Received
(28 days to decision)
Product code
ILE Sling, Arm, Overhead Supported
Regulation
21 CFR 890.3475
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 ILE

Trailing 12 months

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

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