510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822651Substantially Equivalent

Total Finger Flexion Splint

Alimed, LLC, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822651 is the FDA 510(k) clearance record for TOTAL FINGER FLEXION SPLINT, a class I device, cleared for Alimed, Inc. on under FDA product code ILH (Splint, Hand, And Components). FDA records list 11 510(k) clearances for Alimed, Inc., from to . As of , FDA records show no recalls naming K822651.

Clearance record

Decision date
Received
(15 days to decision)
Product code
ILH Splint, Hand, And Components
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Applicant
Alimed, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ILH

Trailing 12 months

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

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