POSEY LAPTOP TRAYS

K963411 · J. T. Posey Co. · FMQ · Nov 19, 1996 · General Hospital

Device Facts

• Record ID: K963411
• Device Name: POSEY LAPTOP TRAYS
• Applicant: J. T. Posey Co.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1

Intended Use

These products are intended to provide postural support and a surface for activities.

Device Story

Posey Laptop Trays provide anterior postural support and activity surface for wheelchair users; secured to wheelchair via hook and loop straps; optional rear strap prevents forward displacement. Used in clinical or home settings; operated by patient or caregiver. Device functions as physical support/restraint; aids patient stability and engagement in activities.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Physical postural support tray; hook and loop strap attachment mechanism; wheelchair-mounted form factor.

Indications for Use

Indicated for patients requiring anterior postural support while seated in a wheelchair. May be used as a surface for activities. If the patient cannot easily self-release the product, it may be considered a restraint.

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

• Posey Laptop Trays (legally marketed by J.T. Posey Co. prior to 1996)

Submission Summary (Full Text)

{0}

NOV-18-1996 12:37 J. T. Posey Co. 818 443 5064 P.05/11

K963411
Customer Service
Toll Free: (800) 44-POSEY
Tel: [phone]
Fax: [phone]

# PAYROLL
# DOLLAR

# Posey Company
5635 Peck Road • Arcadia, California 91006-0020 U.S.A.

## SAFETY AND EFFECTIVENESS SUMMARY

NOV 19 1996

JT Posey Company
5635 Peck Road
Arcadia, CA 91006
Michael Keefe
General Manager
August 30, 1996
Revised: November 18, 1996

Phone # [phone]
FAX # [phone]
Reference Number: K963411

Trade Name: Posey® Laptop Trays
Common Name: Laptop Trays
Classification Name: Protective Restraints

The devices included in this 510(k) submission provide anterior postural support. The products are closed around the wheelchair by hook and loop straps. An optional strap can be secured behind the patient to prevent the tray from being pushed forward. If the patient cannot easily self release the product, it may be considered a restraint.

These products are intended to provide postural support and a surface for activities.

The devices used for comparative purposes are identical to the laptop trays as described in this submission and produced or sold by the J.T. Posey Co. This premarket submission is submitted in response to the agency's final rule published on March 4, 1996 in the Federal Register 21 CFR 880 and 21 CFR 890 Medical Devices, Protective Restraints - Revocation of Exemptions from 510(k) Pre-market Notification Procedures and Current Good Manufacturing Practice Regulation. The June 13, 1996 Meeting Minutes, HIMA Body Holder Task Force and FDA CDRH established the rationale for which devices would be used for comparison:

"Predicate device

FDA indicated that it would be appropriate for manufacturers to reference their current products as legally marketed devices for comparison purposes in their submissions. It would also be appropriate to reference any approved 510(k)s that manufacturers have submitted for their products."

The laptop trays are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Co. as of the date of this submission, August 30, 1996. The limb holders have been manufactured and in commercial distribution for up to 20 years.

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