510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812655Substantially Equivalent

Velcro Splint Strap Fasteners

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

K812655 is the FDA 510(k) clearance record for VELCRO SPLINT STRAP FASTENERS, a class I device, cleared for Maddak, Inc. on under FDA product code ILH (Splint, Hand, And Components). FDA records list 51 510(k) clearances for Maddak, Inc., from to . As of , FDA records show no recalls naming K812655.

Clearance record

Decision date
Received
(8 days to decision)
Product code
ILH Splint, Hand, And Components
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Applicant
Maddak, 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