UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS
K963527 · Alimed, Inc. · FMQ · Oct 31, 1996 · General Hospital
Device Facts
| Record ID | K963527 |
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| Device Name | UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS |
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| Applicant | Alimed, Inc. |
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| Product Code | FMQ · General Hospital |
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| Decision Date | Oct 31, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 880.6760 |
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| Device Class | Class 1 |
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Intended 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.
Indications for Use
Indicated for patients requiring reduced movement in recovery or bed settings, as determined by a healthcare professional.
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
- Various Preamendments General Purpose Straps
Related Devices
- K963490 — PROTECTIVE RESTRAINT - BELTS · Smith and Nephew Donjoy, Inc. · Nov 12, 1996
- K963528 — ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) · Alimed, Inc. · Oct 29, 1996
- K963414 — MULTIPLE BELTS · J. T. Posey Co. · Nov 22, 1996
- K963421 — PROTECTIVE RESTRAINT (WAIST HOLDER) · Kenad SG Medical, Inc. · Nov 22, 1996
- K963470 — CRISS-CROSS VEST RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996
Submission Summary (Full Text)
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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
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# 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 |
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# 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.
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