WHEEL CHAIR ACCESSORY

K963489 · Smith and Nephew Donjoy, Inc. · FMQ · Nov 12, 1996 · General Hospital

Device Facts

• Record ID: K963489
• Device Name: WHEEL CHAIR ACCESSORY
• Applicant: Smith and Nephew Donjoy, Inc.
• Product Code: FMQ · General Hospital
• Decision Date: Nov 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6760
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Safety Poncho, Slider Poncho and the Pelvic Holder are intended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use. These devices are vest and pelvic holder style wheel chair accessories used to assist cooperative patients who require minimum support in a wheelchair.

Device Story

Safety Poncho, Slider Poncho, and Pelvic Holder; wheelchair accessories providing postural support; vest and pelvic holder styles; polyester, cotton, nylon, vinyl mesh or weave substrates; strap-based securement; used in clinical or home settings by cooperative patients; assists patient positioning; prevents sliding/slumping; improves stability; prescription-only.

Clinical Evidence

No clinical data; safety established via four-year commercial history and absence of MDR complaints.

Technological Characteristics

Materials: polyester, cotton, nylon, vinyl; configuration: mesh or weave substrate; securement: strap/tie system; form factor: vest and pelvic holder style wheelchair accessories.

Indications for Use

Indicated for cooperative patients requiring minimum support in a wheelchair. Not for lay use; prescription only.

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-1-96 FRI 14:54 SMITH & NEPHEW DONJOY AX NO. 6194383259 P.05

510(K) Summary
K96-3489

Smith & Nephew DonJoy Inc.
2777 Loker Avenue West
Carlsbad, CA 92008-6601 U.S.A.
Telephone: [phone]
Toll-free: [phone]
Telefax: [phone]

Smith & Nephew

NOV 12 1996

K. SUMMARY OF SAFETY AND EFFECTIVENESS
The Safety Poncho, Slider Poncho and the Pelvic Holder are intended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use. These devices are vest and pelvic holder style wheel chair accessories used to assist cooperative patients who require minimum support in a wheelchair. These devices are made of polyester, cotton, nylon and vinyl configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place. These devices have been commercially distributed for over four years and have not been associated with an MDR type complaint.

Smith & Nephew DonJoy, Inc.

Two
8-28-96

Dan W. Miller
Director of Regulatory Affairs and
Quality Assurance

K963489

5
D
DONJOY