510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963485Substantially Equivalent

Silicone Rubber Cuff/disposable Fleece Liner's Web Torso Resraint,nyon Limb Holder,vinyl Limb Holder,nylon Bed Restrains

Humane Restraint Co., Inc., Waunakee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963485 is the FDA 510(k) clearance record for SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS, a class I device, cleared for Humane Restraint, Inc. on under FDA product code FMQ (Restraint, Protective). FDA records list one 510(k) clearance for Humane Restraint, Inc. As of , FDA records show no recalls naming K963485.

Clearance record

Decision date
Received
(80 days to decision)
Product code
FMQ Restraint, Protective
Regulation
21 CFR 880.6760
Device class
Class I
Review panel
General Hospital
Applicant
Humane Restraint, Inc. 912 Bethel Cir., Waunakee WI
510(k) summary
Summary
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