K963448 · Skil-Care Corp. · FMQ · Oct 7, 1996 · General Hospital
Device Facts
Record ID
K963448
Device Name
ECONO BELT
Applicant
Skil-Care Corp.
Product Code
FMQ · General Hospital
Decision Date
Oct 7, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.6760
Device Class
Class 1
Indications for Use
The Econo Belt is intended for the patient who requires a safety belt while seated in the wheelchair and who requires a reminder not to leave the wheelchair without assistance.
Device Story
Econo Belt; wheelchair safety belt; nylon webbing construction; 2-inch wide, 6-foot long; features sewn loops and metal slider buckles for size adjustment. Positioning: over patient waist, criss-crossed behind wheelchair, looped over kickspurs. Use: wheelchair-bound patients requiring reminders to remain seated. Operation: manual application by caregivers in nursing homes or healthcare facilities. Benefit: provides physical reminder to prevent unassisted exiting of wheelchair; supports compliance with HCFA regulations regarding least restrictive restraint use.
Clinical Evidence
No clinical data provided. Device is a legacy product marketed for approximately 18 years; safety and effectiveness supported by historical market presence and adherence to HCFA regulations regarding restraint use.
Technological Characteristics
Materials: nylon webbing. Dimensions: 2 inches wide, 6 feet long. Components: sewn loops, metal slider buckles. Mechanism: manual mechanical restraint/positioning aid. No electronic, software, or energy-based components.
Indications for Use
Indicated for patients requiring a safety belt while seated in a wheelchair and needing a reminder to remain seated without assistance.
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
Econo Belt (Skil-Care Corporation)
Submission Summary (Full Text)
{0}
Skill-Care CORPORATION
OCT - 7 1996
K963448
167 Saw Mill River Road, Yonkers, New York 10701
(914) 963-2040
(800) 431-2972
FAX (914) 963-2567
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: 1-914-963-2040
Fax: 1-914-963-2567
Contact person: Arnold Silverman
Date summary was prepared: August 27, 1996
Device name:
Trade name: Econo Belt
Common name: Wheelchair Safety Belt
Classification name: Wheelchair Accessory
Predicate device:
Econo Belt marketed by Skil-Care Corporation.
Device Description:
The Econo Belt is a two-inch-wide, six-foot-long wheelchair safety belt made from nylon webbing. Both ends have sewn loops which can be adjusted in size by means of metal slider buckles. The belt is positioned over the patient's waist, criss-crossed behind the wheelchair, and looped over the kickspurs. It is designed for wheelchair use only.
Indications for use:
The Econo Belt is intended for the patient who requires a safety belt while seated in the wheelchair and who requires a reminder not to leave the wheelchair without assistance.
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K963448
## Comparative information:
The device (devices) used for comparative purposes is (are) currently marketed as described in this submission. Device (devices) is (are): Econo Belt.
These devices are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by Skil-Care 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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