← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963527 # UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS (K963527) _Alimed, Inc. · FMQ · Oct 31, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963527 ## Device Facts - **Applicant:** Alimed, Inc. - **Product Code:** [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ.md) - **Decision Date:** Oct 31, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6760 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Reduce patient movement in recover, in bed, or other uses as determined by the health care professiona user. ## Device Story Universal Econo-Strap and QualCraft Universal Straps are general-purpose patient restraints. Fabricated from nylon or nylon and polyethol foam; secured via Velcro or hook-and-loop closures. Used in clinical settings (recovery, bed) to limit patient movement. Operated by healthcare professionals. Device acts as a physical restraint; no electronic or algorithmic components. Benefit includes stabilization of patients during care. ## Clinical Evidence No clinical data. Biocompatibility assessment based on material composition and application method (intervening material between skin and strap). No reports of death, serious injury, or adverse reactions during the manufacturing history. ## Technological Characteristics Materials: Nylon, polyethol foam. Closure: Velcro or hook-and-loop. Form factor: Various lengths and widths (2" to 6" widths; 65" to 96" lengths). Mechanical restraint device; no energy source, connectivity, or software. ## 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 - Various Preamendments General Purpose Straps ## 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} 10-23-1996 10:47AM FROM Curtin & Assrc. Intl. TO 13014803002007 P.03 AliMed inc. 297 High Street Dedham, MA 02026 K963527 OCT 31 1996 # 510(k) SUMMARY ## Various General Purpose Straps Applicant: AliMed®, inc. 297 High Street Dedham, MA 02026 Contact: Jonathan C. Bretz Telephone: 617-329-2900 FAX: 617-329-8392 Submitted by: Curtin & Associates International 1200 East Street Dedham, MA 02026 Contact: Donald A. Lincoln Telephone: 617-329-1955 FAX: 617-329-2529 Date this Summary was prepared: 21 August 1996 Trade Name: Universal Econo-Strap, QualCraft™ Universal Straps Common Name: Strap Classification Name: Patient Restraint Legally Marketed Devices to Which Substantial Equivalence is claimed: Various Preamendments General Purpose Straps (617) 329-2900 • fax: (617) 329-8392 {1} 10-23-1996 10:47AM FROM Curtin & Assrc. Intl. TO 13014803002007 P.04 # 510(k) SUMMARY-continued Description of Device: The devices are fabricated using nylon or nylon and polyethol foam of various lengths and widths as described in advertising. The closure is Velcro® or Velcro®-like hook and loop. Intended Use of the Device: Reduce patient movement in recover, in bed, or other uses as determined by the health care professiona user. | CODE | NAME | SIZE | FIRST MANUFACTURED | USE | | --- | --- | --- | --- | --- | | 7536 | Econo-strap | 3" x 72" | 1990 | General purpose strap | | 7539 | Econo-strap | 4" x 75" | 1990 | General purpose strap | | 91-277 | Universal 1 piece | 2" x 76" | 1989 | General purpose strap | | 91-278 | Universal 1 piece | 3" x 76" | 1989 | General purpose strap | | 91-279 | Universal 1 piece | 4" x 76" | 1989 | General purpose strap | | 91-280 | Universal 1 piece | 6" x 76" | 1989 | General purpose strap | | 91-281 | Universal 1 piece | 2" x 96" | 1989 | General purpose strap | | 91-282 | Universal 1 piece | 3" x 96" | 1989 | General purpose strap | | 91-283 | Universal 1 piece | 4" x 96" | 1989 | General purpose strap | | 91-284 | Universal 1 piece | 6" x 96" | 1989 | General purpose strap | | 91-285 | Universal 2 piece | 2" | 1989 | General purpose straps | | 91-286 | Universal 2 piece | 3" | 1989 | General purpose straps | | 91-287 | Universal 2 piece | 4" | 1989 | General purpose straps | | 91-288 | Universal 2 piece | 6" | 1989 | General purpose straps | | 91-596 | Universal 1 piece | 2" x 65" | 1994 | General purpose strap | | 91-597 | Universal 1 piece | 3" x 65" | 1994 | General purpose strap | | 91-598 | Universal 1 piece | 4" x 65" | 1994 | General purpose strap | | 91-599 | Universal 1 piece | 6" x 65" | 1994 | General purpose strap | 2 {2} 10-23-1996 10:47AM FROM Curtin & Assrc. Intl. TO 13014803002007 P.05 # 510(k) SUMMARY-continued **Comparative Information:** The firm has been unable to locate pre-Amendment catalogs, or similar materials, which relate to this type of general purpose strap. However, it is generally know that they were in use prior to May of 1976 and that they have continued to be supplied by other firms since that time. **Biocompatibility:** Based on the materials used in construction of these straps, and the topological application with the normal use arrangement having some other material between the patient’s skin and the strap, there is little likelyhood of a biocompatibility concern arising. **User Experience:** The firm has received no information related to a death, serious injury or alleged reaction to the materials during the time these devices have been manufactured. 3 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963527](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963527) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com