510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823665Substantially Equivalent

Rotation Boot

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

K823665 is the FDA 510(k) clearance record for ROTATION BOOT, a class I device, cleared for Warm & Form, Orthopedic Materials on under FDA product code KNP (Orthosis, Corrective Shoe). FDA records list 24 510(k) clearances for Warm & Form, Orthopedic Materials, from to . As of , FDA records show no recalls naming K823665.

Clearance record

Decision date
Received
(24 days to decision)
Product code
KNP Orthosis, Corrective Shoe
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Applicant
Warm & Form, Orthopedic Materials 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KNP

Trailing 12 months

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

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