← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963448 # ECONO BELT (K963448) _Skil-Care Corp. · FMQ · Oct 7, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963448 ## Device Facts - **Applicant:** Skil-Care Corp. - **Product Code:** [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ.md) - **Decision Date:** Oct 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6760 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. 17 {1} 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. 18 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963448](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963448) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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