LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER

K963456 · Skil-Care Corp. · FMQ · Oct 8, 1996 · General Hospital

Device Facts

• Record ID: K963456
• Device Name: LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER
• Applicant: Skil-Care Corp.
• Product Code: FMQ · General Hospital
• Decision Date: Oct 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Intended Use

The Reusable Limb Holders, Disposable Limb Holders, and Quik Cuff Limb Holders are intended for patients who require limitations placed on their hand and leg movement.

Device Story

Limb holders consist of synthetic sheepskin or polyurethane foam cuffs with polyester webbing straps, metal buckles, or Delrin d-rings and Velcro closures. Used in clinical settings to restrict patient limb movement. Applied by healthcare staff to patients requiring restraint for medical treatment. Devices secure limbs to prevent movement; usage governed by HCFA regulations prohibiting use for discipline or convenience. Benefit includes ensuring patient safety and appropriate medical treatment under supervision.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: synthetic sheepskin, polyurethane foam, polyester webbing, metal buckles, Delrin d-rings, Velcro hook/loop. Form factor: cuff with straps. Mechanical restraint device; no energy source or software.

Indications for Use

Indicated for patients requiring limitation of hand and leg movement.

Regulatory Classification

Identification

A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

Predicate Devices

• Reusable Limb Holder (Skil-Care Corporation)
• Disposable Limb Holder (Skil-Care Corporation)
• Quik-Cuff Limb Holder (Skil-Care Corporation)

Submission Summary (Full Text)

{0}

Skil-Care CORPORATION
OCT - 8 1996
K963456
167 Saw Mill River Road, Yonkers, New York 10701
[phone]
[phone]
FAX [phone]

# TAB F: 510(k) Summary of Safety and Effectiveness

Name, address, phone and fax numbers for person submitting the 510(k) notification:

Arnold Silverman, President
Skil-Care Corporation
167 Saw Mill River Road
Yonkers, NY 10701
Phone: [phone]
Fax: [phone]

Contact person: Arnold Silverman

Date summary was prepared: August 27, 1996

Device name:

Trade name: Reusable Limb Holder, Disposable Limb Holder, Quik-Cuff Limb Holder

Common name: Limb Holder

Classification name: Protective Restraint

Predicate device:

Reusable Limb Holder, Disposable Limb Holder, and Quik-Cuff Limb Holder marketed by Skil-Care Corporation.

Device Description:

Disposable Limb Holder (Synthetic Sheepskin-Double Tie): These limb holders have a 2 1/2-inch-wide by 12-inch-long synthetic cuff to which is sewn a 19-inch-long wrist strap. The wrist strap is 1 1/8-inch-wide polyester webbing. It is terminated with a 1 1/4-inch-wide metal buckle. Approximately 2 1/2 inches back from the buckle a 102-inch-long strap (doubled to form two 51-inch-long sections) is sewn to the wrist band. Just beyond the point where this strap is attached, a one-inch-wide, seven-inch-long strip of Velcro loop material is sewn to the cuff. A 2 1/2-inch-long Velcro hook tab is stitched to the same end of the cuff as the buckle. The Velcro hook and loop position the cuff on the wrist or ankle, the wrist strap and buckle secure the device. Sold in pairs.

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K963456

Disposable Limb Holders (Synthetic Sheepskin-Single Tie): Identical to the above except that they have a single 51-inch-long strap sewn to the wrist strap.

Disposable Limb Holders (Foam-Double Tie): Identical in construction to the Disposable Limb Holders (Synthetic Sheepskin-Double Tie) except that the cuff is made from 1/4-inch-thick polyurethane foam back with Velcro loop material.

Disposable Limb Holders (Foam-Single Tie): Identical to above except that they have a single 51-inch-long strap sewn to the wrist strap.

Reusable Synthetic Sheepskin Limb Holders: These limb holders have a 2 1/2-inch-wide, 12-inch-long synthetic sheepskin cuff to which is sewn a 19-inch-long, 1 1/8-inch-wide polyester wrist strap. The wrist strap is terminated with a metal buckle. A polyester strap of 1 1/8 inches in width is stitched to the wrist band approximately 2 1/2 inches beyond the buckle. This strap is 102-inches-long and is doubled to form two 51-inch-long sections.

Quik-Cuff Limb Holders: These have a 2 1/2-inch-wide, 12-inch-long synthetic sheepskin cuff to which is attached a 19-inch-long, one-inch-wide Velcro backstrap that includes a one-inch-wide Delrin d-ring through which the Velcro is secured. A single, 51-inch long strap is stitched to the cuff and the backstrap approximately at the center of the cuff.

## Indications for use:

The Reusable Limb Holders, Disposable Limb Holders, and Quik Cuff Limb Holders are intended for patients who require limitations placed on their hand and leg movement.

## Comparative information:

The device (devices) used for comparative purposes is (are) currently marketed as described in this submission. Device (devices) is (are): The Disposable Limb Holder, Reusable Limb Holder, and the Quik-Cuff Limb Holder.

These devices are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by Skil-Care

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K963456

Corporation as of the date of this submission. Skil-Care Corporation has been marketing and commercially distributing these devices for approximately 18 years.

The difference from our currently marketed devices are that the labeling will be changed to incorporate many of the suggestions in FDA's draft document, "Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints.

The use of all patient restraints in nursing homes are subject to Health Care Financing Administration's Regulations which prohibit the use of any restraint, physical or chemical, imposed for the purpose of discipline or convenience. Further, most health care facilities are accredited. HCFA rules governing appropriate use and accreditation standards for device use and personnel training provide the control necessary to ensure that the devices are used correctly. The application of these standards along with public awareness and health care provider training have contributed significantly to ensuring that the least restrictive restraint is used, that restraints are used only when needed for proper medical treatment, and that their use is under appropriate supervision.

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