POSEY HUGGER

K963409 · J. T. Posey Co. · FMQ · Nov 14, 1996 · General Hospital

Device Facts

• Record ID: K963409
• Device Name: POSEY HUGGER
• Applicant: J. T. Posey Co.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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

Device Story

Posey® Hugger; anterior postural support device for wheelchair users. Foam-based design; inserted into wheelchair arms; compresses to fit; expands to secure position. Provides surface for activities. Used in clinical or home settings; operated by patient or caregiver. Output is physical support/stabilization. Benefits include improved posture and activity surface.

Technological Characteristics

Foam-based anterior postural support; wheelchair accessory; mechanical compression/expansion fit.

Indications for Use

Indicated for patients requiring anterior postural support while seated in a wheelchair. 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.

Submission Summary (Full Text)

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NOV-13-1996 15:20 J. T. Posey Co. B1B 443 5064 P.02/03

K963409
Customer Service
Toll Free: (800) 44-POSFY
Tel: [phone]
Fax: [phone]

NOV 14 1996

# SAFETY AND EFFECTIVENESS SUMMARY

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

Phone # [phone]
FAX # [phone]

JT Posey Company
5635 Peck Road
Arcadia, CA 91006
Michael Keefe
General Manager
August 30, 1996
Revised: November 13, 1996
Reference Number: K963409

Trade Name: Posey® Hugger
Common Name: Hugger
Classification Name: Wheelchair Accessory

The devices included in this 510(k) submission provide anterior postural support. The products are inserted into the arms of the wheelchair compressing the foam and releasing it once in position. 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 huggers as described in this submission and produced or sold by the J.T. Posey Co. 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 huggers are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by JT Posey Company as of the date of this submission, August 30, 1996.

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