← Product Code [FMQ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ) · K963526 # STRAP WEDGE (K963526) _Alimed, Inc. · FMQ · Oct 28, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963526 ## 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 28, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6760 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Position and secure a patient in the prone or supine positions. ## Device Story Strap Wedge consists of covered foam blocks with five sewn-in restraining straps. Used to position and secure patients in prone or supine positions. Operated by healthcare personnel in clinical settings. Device provides physical stabilization; aids in patient positioning for clinical procedures or care. Benefits include patient stability and maintenance of required orientation. ## Clinical Evidence No clinical data. Biocompatibility assessment based on topological use and historical manufacturing data; no reports of death or serious injury since initial manufacture in September 1995. ## Technological Characteristics Assembly of covered foam blocks with five sewn-in restraining straps. Mechanical 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 strap and support assemblies ## 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} 10-21-1996 01:07PM FROM Curtin & Assrc. Intl. TO 13014803002007 P.03 AliMed inc. 297 High Street Dedham, MA 02026 OCT 28 1996 X963526 # 510(k) SUMMARY ## Strap Wedge 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: 30 August 1996 Trade Name: Strap Wedge Common Name: Strap Wedge Classification Name: Patient Restraint Legally Marketed Devices to Which Substantial Equivalence is claimed: Various Preamendments strap and support assemblies. (617) 329-2900 • fax: (617) 329-8392 TOTAL P.03 {1} 10-21-1996 01:06PM FROM Curtin & Assrc. Intl. TO 13014803002007 P.02 # 510(k) SUMMARY-continued Description of Device: The Strap Wedge is an assembly of covered foam blocks to which five (5) restraining straps have been sewn. Intended Use of the Device: Position and secure a patient in the prone or supine positions. User Experience: There have been no reports of death or serious injury received by the firm during the time these devices have been manufactured. Device was first manufactured in September of 1995. Biocompatibility: Based on the topological use of this device and the materials used, it is unlikely that biocompatibility difficulties would arise. In addition, the firm has received no information from users indicating that a biocompatibility question has developed. Comparative Information: The firm has been unable to obtain pre-1976 information related to specific devices of this type. However, the use of covered foam padding and straps such as are incorporated in this device appear to have been in use before the Medical Device Amendment as well as after the date of the amendment. 2 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963526](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMQ/K963526) **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