510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K963453Substantially Equivalent

Cfi Restraint Belt (Cfi-168) / Cfi Restraint Belt (Cfi-4046)

Domico Med-Device, LLC, Grand Blanc MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963453 is the FDA 510(k) clearance record for CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046), a class I device, cleared for Contour Fabricators, Inc. on under FDA product code FMQ (Restraint, Protective). FDA records list 8 510(k) clearances for Domico Med-Device, LLC, from to . As of , FDA records show no recalls naming K963453.

Clearance record

Decision date
Received
(73 days to decision)
Product code
FMQ Restraint, Protective
Regulation
21 CFR 880.6760
Device class
Class I
Review panel
General Hospital
Applicant
Contour Fabricators, Inc. 4100 E. Baldwin Ave., Grand Blanc MI
510(k) summary
Statement
Third party review
No

Clearances, product code FMQ

Trailing 12 months

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

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