510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823162Substantially Equivalent

Universal Sling, Sling & Swathe

Warm & Form, Orthopedic Materials, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823162 is the FDA 510(k) clearance record for UNIVERSAL SLING, SLING & SWATHE, a class I device, cleared for Warm & Form, Orthopedic Materials on under FDA product code ILI (Sling, Arm). FDA records list 24 510(k) clearances for Warm & Form, Orthopedic Materials, from to . As of , FDA records show no recalls naming K823162.

Clearance record

Decision date
Received
(16 days to decision)
Product code
ILI Sling, Arm
Regulation
21 CFR 890.3640
Device class
Class I
Review panel
Physical Medicine
Applicant
Warm & Form, Orthopedic Materials 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ILI

Trailing 12 months

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

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