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510(k) Data Aggregation
K Number
K963485Device Name
SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS
Manufacturer
Date Cleared
1996-11-22
(80 days)
Product Code
Regulation Number
880.6760Why did this record match?
Applicant Name (Manufacturer) :
HUMANE RESTRAINT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Other than the fleece liner, all devices are intended to limit movement of severely agitated persons who may cause harm to themselves or to others if not restrained. The fleece liner is an accessory to reduce chatling when used with the silicone rubber cuff. Where locks are a part of the device, they are for the purpose of lessening the chance of unauthorized release.
Device Description
- Silicone Rubber Cuff: The device is made of silicone rubber molded over a 0.015 inch mylar insert. A nickel plated oblong shaped steel loop is riveted on one end that can be inserted into one of 5 slots on the other end as the first step in securing
- Disposable Fleece Liner: The disposable fleece liner is made of a soft, disposable fleece material that is designed to be placed over the cuff to reduce chafing.
- Web Torso Restraint: The device is a 2 inch wide nylon webbing strap with either two sewn on L-400 lock or two sewn-on 2 inch polyethylene side-release buckle with 2 inch slide bar, each attached 28 inches from the end.
- Nylon Limb Holder: The device is a 2 inch wide nylon webbing strap with either two sewn on L-400 lock or two sewn-on 2 inch polyethylene side-release buckle with 2 inch slide bar, each attached 14 inches (wrist) or 9 inches (ankle) from the center.
- Vinyl Limb Holder: The device is a 2 inch wide vinyl strap with either two sewn on L-400 lock or two sewn-on 2 inch polyethylene side-release buckle with 2 inch slide bar, each attached 14 inches (wrist) or 9 inches (ankle) from the center.
- Nylon Bed Restraints (Wrist): The device is attached to the bed frame using a 2 inch x 12 foot nylon webbing strap with either two sewn on L-400 lock or two sewn-on 2 inch polyethylene side-release buckle with 2 inch slide bar, each attached 38 inches from each end. Two 2 inch x 12 inch (wrist) or two 2 inch x 14 inch (ankle) fleece-lined culls are sewn on to the 64 inch length of nylon webbing each either 14 inches (wrist) or 9 inches (ankle) from the center. The culls are available with a choice of 4 different types of closures: a 1 inch polyethylene side release buckle with 1 inch polyethylene slide bar, an L-400 lock, a 1 ½ inch double D ring buckle, or a polypropylene web buckle.
- Nylon Torso Restraint: A 2 inch x 96 inch nylon webbing torso restraint is available in one size. The restraint is place over the chest or upper legs and secured to a bed with cither two L-400 lock buckles or two 2 inch polyethylene side-release buckle, each sewn 28 inches from the end. The restraint is optional for use with wrist restraints to prevent the restrained person from sitting up in the bed.
- Nylon Transporter: This device consists of a 2 inch x 64 inch nylon webbing waist belt with two 2 inch x 12 inch nylon webbing wrist culls sewn on, the first 9 inches from the keeper, the second, 13 inches from the first. The waist belt is secured in back with a 2 inch polyethylene side release lock with 2 inch slider bar, the wrist cuffs are double secured with 4 1/4 inches of 1-1/2 inch hook and loop closure and twin D rings sewn onto the cuff along with a 1 inch x 18 inch black nylon webbing strap to cinch the D rings.
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