(43 days)
Not Found
Not Found
No
The device description and intended use clearly describe physical restraints made of nylon web and knit material with buckles or hook and loop closures. There is no mention of any computational or data-driven components.
No.
The device acts as a restraint or safety measure, providing support and preventing falls, rather than directly treating a medical condition or ailment.
No
The device is a physical restraint, a safety belt for wheelchairs, designed to remind patients to stay in their wheelchair or prevent falls. It performs no diagnostic function.
No
The device description clearly outlines physical components made of nylon web and other materials, and the intended use describes a physical restraint. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a physical restraint for patients in wheelchairs to help them stay seated, prevent falls, or feel safer. It is used in conjunction with a medical treatment program and nursing care.
- Device Description: The device is described as a physical belt made of nylon web or padded material with various closure mechanisms (slide buckle, adjustable loop, hook and loop, quick release buckle).
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with biological samples or perform any diagnostic testing.
The device is a physical restraint used for patient safety and management, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
Medline Wheelchair Safety Belt Restraints are intended for use with patients or residents that need a "gentle reminder" for the patient to stay in their wheelchair or to remind them to seek assistance before standing. These products are also intended to help prevent falls or to help the patient feel safer in their wheelchair. Several of the designs are intended to enable the user to release them, per O.B.R.A. regulations. These products are designed for use with a carefully defined medical treatment program which addresses (but is not limited to) restorative nursing, patient release, and pressure sore prevention. Aggressive, agitated or restless patients require increased monitoring and a systematic review and evaluation of both their physical and psychological status.
Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, for patients that are at risk for a life threating fall or fall that may cause serious injury or re-injury, or to help patients feel safer in wheelchair.
Medline Wheelchair Safety Belt Restraints are not intended for use with stretchers, on toilets or shower chairs or in the shower or tub.
Medline Patient Safety Products are not intended for use in a motorized vehicle, as they are not designed to withstand the force of a crash.
Medline Patient Safety Products are not intended for home use.
These devices are for use in hospitals and/or nursing homes to help maximize patient safety and are not intended to preclude good nursing care and common sense.
Product codes
Not Found
Device Description
Medline's Wheelchair Safety Belts are intended to be utilized as a "gentle reminder" for patients to stay in their wheelchair or not to attempt to stand without assistance. They are intended to help the patient feel safer or more secure in their wheelchair. Two of the items are designed to be able to be released by the patient.
The first two items are not designed to be released by the wearer:
-
A. Wheelchair Waist Belt
Made of 2" nylon web. Belt circles patient's waist and passes through a slid buckle in front for individual fit. Belt criss-crosses in back and attaches to kick spurs at rear of wheelchair. -
B. Economy Wheelchair Belt
Made of 2" nylon web. Similar to the Wheelchair Waist Belt except this item does not have the slide buckle in front. Belt goes around wearer's waist and attaches to the kick spurs using an adjustable loop.
The following three items are designed to be released by the wearer:
-
C. Two-Piece Safety Soft Belt
Hook and Loop (Velcro) closure enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations. Padded belt made of blue knit material for extra comfort. -
D. Wheelchair Belt with Buckle
Made of 2" nylon web. Quick release buckle enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations. -
ய் Wheelchair Belt with Hook & Loop
Made of 2" nylon web. Hookk and Loop closure in the front enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's waist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and/or nursing homes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A total of thirteen articles were reviewed for this 510(k) submission. The articles listed in the citation contained pertinent data for establishing the safety and efficacy of protective restraints.
Specific safety and effectiveness data outlined in the literature include actual as well as potential complications which may occur and are summarized as follows:
Emotional desolation, agitation, fractures, chafing, burns, nerve damage, circulatory impairment, decubitus ulcers, death, and strangulation attributed to incorrect supervision, handling or application of protective restraint devices by medical or paramedical personnel. These incidences seem to be the result of inappropriate patient selection (physically restraining a patient for whom physical restraint is contraindicated), incorrect restraint selection, errors in correctly applying the device, and/or inadequate monitory of patients when restrained.
When used correctly and for indicated circumstances, protective restrains provide benefits to many patients, such as precluding patients with temporary medical related cognitive deficits from impairing the resolution of their physical problems by involuntarily discontinuing life-support or other needed medical interventions, temporarily reducing the mobility of agitated patients, or helping patients feel safer in a bed or wheelchair.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6760 Protective restraint.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the word "MEDLINE" in bold, italicized font. Below the word is a compass-like symbol with four points. The top point is wider than the bottom point.
Medline Industries, Inc.
One Medline Place Mundelein, Illinois 60060.4486
1.847.949.3109 1.800.950.0128 Fax 1.847.949.2643
Corporate Quality Assurance/Regulatory Affairs
SAFETY AND EFFECTIVENESS SUMMARY
Medline Industries, Inc. One Medline Place Mundelein, IL 60060 Phone #: (847) 949-2639 Fax #: (847) 949-2643 Lara N. Simmons Corporate Regulatory Affairs Manager
OCT 1 8 1996
August 29, 1996
Device Name: Wheelchair Accessory, Wheelchair Safety Belt Proprietary: Medline Wheelchair Safety Belt, Medline Two-Piece Safety Soft Belt, Medline Wheelchair Belt, Medline Wheelchair Lock Belt Common: Wheelchair Belt Classification: Wheelchair Accessory
These devices have been legally marketed prior to the date of this submission. The intended use and claims, technological features, materials and physical and mechanical specifications have not been changed.
1.0 General Description
.......
Medline's Wheelchair Safety Belts are intended to be utilized as a "gentle reminder" for patients to stay in their wheelchair or not to attempt to stand without assistance. They are intended to help the patient feel safer or more secure in their wheelchair. Two of the items are designed to be able to be released by the patient.
The first two items are not designed to be released by the wearer:
-
A. Wheelchair Waist Belt
Made of 2" nylon web. Belt circles patient's waist and passes through a slid buckle in front for individual fit. Belt criss-crosses in back and attaches to kick spurs at rear of wheelchair. -
B. Economy Wheelchair Belt
Made of 2" nylon web. Similar to the Wheelchair Waist Belt except this item does not have the slide buckle in front. Belt goes around wearer's waist and attaches to the kick spurs using an adjustable loop.
1
The following three items are designed to be released by the wearer:
-
C. Two-Piece Safety Soft Belt
Hook and Loop (Velcro) closure enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations. Padded belt made of blue knit material for extra comfort. -
D. Wheelchair Belt with Buckle
Made of 2" nylon web. Quick release buckle enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations. -
ய் Wheelchair Belt with Hook & Loop
Made of 2" nylon web. Hookk and Loop closure in the front enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations.
INTENDED USE
Medline Wheelchair Safety Belt Restraints are intended for use with patients or residents that need a "gentle reminder" for the patient to stay in their wheelchair or to remind them to seek assistance before standing. These products are also intended to help prevent falls or to help the patient feel safer in their wheelchair. Several of the designs are intended to enable the user to release them, per O.B.R.A. regulations. These products are designed for use with a carefully defined medical treatment program which addresses (but is not limited to) restorative nursing, patient release, and pressure sore prevention. Aggressive, agitated or restless patients require increased monitoring and a systematic review and evaluation of both their physical and psychological status.
Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, for patients that are at risk for a life threating fall or fall that may cause serious injury or re-injury, or to help patients feel safer in wheelchair.
Medline Wheelchair Safety Belt Restraints are not intended for use with stretchers, on toilets or shower chairs or in the shower or tub.
Medline Patient Safety Products are not intended for use in a motorized vehicle, as they are not designed to withstand the force of a crash.
Medline Patient Safety Products are not intended for home use.
These devices are for use in hospitals and/or nursing homes to help maximize patient safety and are not intended to preclude good nursing care and common sense.
2
A reasonable search of all information known or otherwise presently available to Medline Industries, Inc. has been conducted. Such a search is defined as examining articles in medical literature, and company documents concerning safety and effectiveness information for safety restraints. Following is a summary of and citation to the safety and effectiveness data found in that search.
Specific safety and effectiveness data outlined in the literature include actual as well as potential complications which may occur and are summarized as follows:
Emotional desolation, agitation, fractures, chafing, burns, nerve damage, circulatory impairment, decubitus ulcers, death, and strangulation attributed to incorrect supervision, handling or application of protective restraint devices by medical or paramedical personnel. These incidences seem to be the result of inappropriate patient selection (physically restraining a patient for whom physical restraint is contraindicated), incorrect restraint selection, errors in correctly applying the device, and/or inadequate monitory of patients when restrained.
When used correctly and for indicated circumstances, protective restrains provide benefits to many patients, such as precluding patients with temporary medical related cognitive deficits from impairing the resolution of their physical problems by involuntarily discontinuing life-support or other needed medical interventions, temporarily reducing the mobility of agitated patients, or helping patients feel safer in a bed or wheelchair.
Medline Industries, Inc. offers a variety of additional materials to help insure the safe and proper use of it's patient safety products, including posters and videos. Medline Industries, Inc. stresses the importance of patient monitoring, and that these products should only be used upon advice of a physician or other trained, licensed healthcare professional.
A total of thirteen articles were reviewed for this 510(k) submission. The articles listed in the citation contained pertinent data for establishing the safety and efficacy of protective restraints.
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