ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)
K963528 · Alimed, Inc. · FMQ · Oct 29, 1996 · General Hospital
Device Facts
| Record ID | K963528 |
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| Device Name | ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) |
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| Applicant | Alimed, Inc. |
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| Product Code | FMQ · General Hospital |
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| Decision Date | Oct 29, 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
Reduction of patient movement, or restrain of patient, during medical procedure, during transportation of the patient, or in other situation s deemed appropriate by the health car facility.
Device Story
AliMed Positioning & Safety Straps, Semi-Disposable Arm Straps, and Stretcher Straps are fabric-based restraints; utilize hook-and-loop closures for securing patients; used in clinical settings, medical procedures, or patient transport; operated by healthcare facility staff; function by physically limiting patient movement; benefit patient by ensuring safety and stability during care or transit.
Clinical Evidence
No clinical data. Safety profile based on historical market experience; no reports of death, serious injury, or allergic reactions since initial marketing.
Technological Characteristics
Fabric straps of various lengths/widths; hook-and-loop closure mechanism; topical application; non-sterile.
Indications for Use
Indicated for patients requiring movement reduction or restraint during medical procedures, transport, or other clinical situations as determined by healthcare facilities.
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 straps and restraints
Related Devices
- K963414 — MULTIPLE BELTS · J. T. Posey Co. · Nov 22, 1996
- K963527 — UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS · Alimed, Inc. · Oct 31, 1996
- K963387 — DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP · Morrison Medical Products · Nov 8, 1996
- K963371 — BEST STRAP RESTRAINT · Morrison Medical Products · Nov 7, 1996
- K962429 — SAFETY VEST · Johnson & Johnson Professionals, Inc. · Sep 18, 1996
Submission Summary (Full Text)
{0}
AliMed inc.
297 High Street
Dedham, MA 02026
OCT 29 1996
963528
# 510(k) SUMMARY
## Various Procedural Restraints
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: 27 August 1996
Trade Names: AliMed® Positioning & Safety Straps, Semi-Disposable Arm Straps, Stretcher Straps
Common Name: Strap or Restraint
Classification Name: Patient Restraint
Legally Marketed Devices to Which Substantial Equivalence is claimed:
Various Preamendments straps and restraints.
(617) 329-2900 • fax: (617) 329-8392
{1}
510(k) SUMMARY-continued
Description of Device: The devices are fabricated various lengths and widths as described in advertising. The closure is "hook and loop".
Intended Use of the Device: Reduction of patient movement, or restrain of patient, during medical procedure, during transportation of the patient, or in other situation s deemed appropriate by the health car facility.
| CODE | NAME | SIZE | FIRST MANUFACTURED | USE |
| --- | --- | --- | --- | --- |
| 9-931 | Universal Body Strap | 5" x 65" | 1990 | Positioning & safety strap |
| 9-930 | Wrist/Ankle Straps | 1 @ 5" x 45"
2 @ 2" x 12" | 1991* | Positioning patient on table |
| 9-950 | Wrist Straps | 2 @ 2" x 12" | 1991 | Restraint wrists/arms |
| 95-022 | Semi-Disposable Arm Straps | 2" x 18" | 1986 | Bulk arm strap |
| 7686 | Wheel Stretcher Strap | 2" x 62" | 1978** | Stretcher strap |
| 7687 | Wheel Stretcher Strap | 2" x 66" | 1978** | Stretcher strap |
| 7688 | Wheel Stretcher Strap | 2" x 72" | 1978** | Stretcher strap |
* = Converted from Distributed by to Manufactured by in the year shown. First year of sale by original company not know at this time.
** = Converted from Distributed by to Manufactured for, by the actual manufacturer. Date shown is that firm's drawing date.
Comparative Information: Pre-1976 catalogs were not found which showed devices such as those contained in this notification. However, it is understood that these types of devices were in use prior to the Medical Device Amendment and others were introduced after the Act.
Biocompatibility: Based on the materials, and the method of use (topological), it is unlikely that any concern of this nature would develop.
User Experience: The firm has received no information related to a death, serious injury or allergenic reaction to the materials used during the time these devices have been marketed.
