STRAP WEDGE

K963526 · Alimed, Inc. · FMQ · Oct 28, 1996 · General Hospital

Device Facts

• Record ID: K963526
• Device Name: STRAP WEDGE
• Applicant: Alimed, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Oct 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

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.

Indications for Use

Indicated for patients requiring positioning and securement in prone or supine positions.

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 strap and support assemblies

Submission Summary (Full Text)

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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: [phone]
FAX: [phone]

Submitted by:
Curtin & Associates International
1200 East Street
Dedham, MA 02026
Contact: Donald A. Lincoln
Telephone: [phone]
FAX: [phone]

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.

[phone] • fax: [phone]
TOTAL P.03

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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.

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