PATIENT RESTRAINTS

K963906 · Safety Intl., Inc. · FMQ · Dec 2, 1996 · General Hospital

Device Facts

• Record ID: K963906
• Device Name: PATIENT RESTRAINTS
• Applicant: Safety Intl., Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Dec 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Indications for Use

The Safety International Corp. Restraint Belt is designed to effectively secure the patient on a ambulance cot, backboard, stretcher or wheelchairs. They are also used for application as wrist or ankle restraints in conjunction with the patient restraints already on the equipment on which the patient is being carried.

Device Story

Patient restraint belts used to secure individuals to ambulance cots, backboards, stretchers, or wheelchairs; also used as wrist/ankle restraints. Device consists of 2-inch wide nylon or polypropylene webbing with a chrome-plated metal push-button buckle. Buckle provides positive closure and corrosion resistance. Adjustable length via pull-strap mechanism. Used in clinical or emergency transport settings by medical personnel. Benefits include patient stabilization during transport and prevention of falls or injury.

Clinical Evidence

No clinical data. Substantial equivalence determination based on design and material similarity to predicate devices.

Technological Characteristics

2-inch wide nylon or polypropylene webbing; chrome-plated metal push-button buckle; non-sterile, reusable; manual adjustment mechanism.

Indications for Use

Indicated for securing patients to ambulance cots, backboards, stretchers, or wheelchairs; also indicated for use as wrist or ankle restraints in conjunction with existing equipment restraints.

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

• Abco Restraint, Protective (K850470)
• Biomet Restraint, Protective (K780232)
• Dowling Textile Restraint, Protective (K760618)
• Maddak Restraint, Protective (K812473)
• Medical Restraints Restraints, Protective (K771629)

Reference Devices

• Morrison Medical Products Restraint (not specified)

Submission Summary (Full Text)

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K963906

DEC - 2 1996

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K963906

## Submitted By:

George Bolukbas, President
Safety International Corp.
160 Lyman Rd.
Casselberry, FL 32707
Tel [phone]
Fax [phone]

Date Prepared: September 26, 1996

## Device Name

Proprietary Name: Patient Restraints
Common Name: Belts
Classification Name: Protective Restraints (880.6760)

## Substantial Equivalence Claim

Safety International Corp. Belts are similar in indications, design and features to various Protective Restraints that FDA has found to be substantially equivalent to the pre-amendment devices. The following are some such devices:

| Manufacturer | Product | 510(k) Number |
| --- | --- | --- |
| | | |
| Abco | Restraint, Protective | K850470 |
| Biomet | Restraint, Protective | K780232 |
| Dowling Textile | Restraint, Protective | K760618 |
| Maddak | Restraint, Protective | K812473 |
| Medical Restraints | Restraints, Protective | K771629 |

## Device Description

The Safety International Corp.'s Patient Restraints are easy to use devices which are used to secure patients to a ambulance cot, backboard, stretcher or wheelchairs. The belts utilize 2 inch wide, 2 piece nylon web with quick release automatic push button buckle. Auto chrome plated metal push button buckle provides positive closure and resists rust and corrosion. Buckle end is sewn and the adjusted end provides adjustment on the size of the restraints for the patient by pulling the open end of the restraint and adjusting to the

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desired size. The belts are available in black, orange, burgundy, blue, red and yellow. The material used for the web is either nylon or polypropylene and has been in use with no adverse effects.

## Intended Use

The Safety International Corp. Restraint Belt is designed to effectively secure the patient on a ambulance cot, backboard, stretcher or wheelchairs. They are also used for application as wrist or ankle restraints in conjunction with the patient restraints already on the equipment on which the patient is being carried.

## Biocompatibility

The material used for the web is either nylon or polypropylene and has been in use with no adverse effects. The same materials are used in the above mentioned substantially equivalent products.

## Substantial Equivalence Comparison

| | Safety International Corp. | Morrison Medical Products |
| --- | --- | --- |
| Indication | Secure the patient on a ambulance cot, backboard, stretcher or wheelchairs. | Secure the patient on a ambulance cot, backboard, stretcher or wheelchairs. |
| Mode Of Operation | Strap with male connector on one end and female on the other lock together. | Strap with male connector on one end and female on the other lock together. |
| Material | Nylon webbing. | Nylon webbing. |
| Sterility | Nonsterile/reusable | Nonsterile/reusable |

The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical.