SAFETY PONCHO/SHOULDER STRAP PONCHO

K963461 · Skil-Care Corp. · KID · Oct 11, 1996 · Physical Medicine

Device Facts

• Record ID: K963461
• Device Name: SAFETY PONCHO/SHOULDER STRAP PONCHO
• Applicant: Skil-Care Corp.
• Product Code: KID · Physical Medicine
• Decision Date: Oct 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3910
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Safety Poncho is used for restraint. The Shoulder Strap Poncho provides restraint and posture support.

Device Story

Poncho-style upper body restraints; constructed from woven polyester or polyester mesh; secured to wheelchair kickspurs via 1 1/8-inch polyester webbing waist strap. Shoulder Strap Poncho includes additional shoulder strap for attachment to wheelchair pushhandles for posture support. Used in clinical/nursing home settings; operated by healthcare staff. Provides physical restraint and posture stabilization; intended to ensure patient safety and proper positioning. Clinical decision-making guided by HCFA regulations and facility accreditation standards to ensure least restrictive intervention.

Clinical Evidence

No clinical data; bench testing only. Safety and effectiveness supported by 18 years of commercial history and adherence to HCFA regulations regarding restraint use in healthcare facilities.

Technological Characteristics

Materials: Woven polyester or polyester mesh; 1 1/8-inch polyester webbing straps. Form factor: Poncho-style garment. Mechanical restraint/support principle. No energy source, software, or connectivity.

Indications for Use

Indicated for patients in nursing homes or healthcare facilities requiring physical restraint or posture support while seated in a wheelchair. Contraindicated for use for discipline or convenience; must be used only for medical treatment under appropriate supervision.

Regulatory Classification

Identification

A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap.

Predicate Devices

• Safety Poncho (Skil-Care Corporation)
• Slider Poncho (Skil-Care Corporation)

Submission Summary (Full Text)

{0}

Skill-Care CORPORATION
K963461
167 Saw Mill River Road, Yonkers, New York 10701
[phone]
[phone]
FAX [phone]

TAB F: 510(k) Summary of Safety and Effectiveness

Name, address, phone and fax numbers for person submitting the 510(k) notification:

Arnold Silverman, President
Skil-Care Corporation
167 Saw Mill River Road
Yonkers, NY 10701
Phone: [phone]
Fax: [phone]

Contact person: Arnold Silverman

Date summary was prepared: August 27, 1996

Device name:

Trade name: Safety Poncho, Shoulder Strap Poncho
Common name: Same
Classification name: Wheelchair Accessory

Predicate device:

Safety Poncho and Slider Poncho marketed by Skil-Care Corporation.

Device Description:

Safety Poncho: A poncho-style, upper body device made from either woven polyester or polyester mesh. A waist strap secures the device to the wheelchair kickspurs. The strap is 1 1/8-inch-wide polyester webbing. The edges of the garment are finished with a bias cut binding, the color of which corresponds to a size chart included on the package insert. The device is intended for wheelchair use only.

Shoulder Strap Poncho: The Shoulder Strap Poncho has the same configuration as the above with the addition of a strap sewn on the shoulder area. This strap ties to the wheelchair pushhandles to provide posture support. Strap is 1 1/8-inch-wide polyester webbing.

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K963461

## Indications for use:

The Safety Poncho is used for restraint.

The Shoulder Strap Poncho provides restraint and posture support.

## Comparative information:

The device (devices) used for comparative purposes is (are) currently marketed as described in this submission. Device (devices) is (are): The Safety Poncho and the Shoulder Strap Poncho.

These devices are currently exempt from 510(k) Premarket Notification Procedures and Good Manufacturing Practice Regulations and are legally marketed by Skil-Care Corporation as of the date of this submission. Skil-Care Corporation has been marketing and commercially distributing these devices for approximately 18 years.

The difference from our currently marketed devices are that the labeling will be changed to incorporate many of the suggestions in FDA’s draft document, "Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective Restraints.

The use of *all* patient restraints in nursing homes are subject to Health Care Financing Administration’s Regulations which prohibit the use of any restraint, physical or chemical, imposed for the purpose of discipline or convenience. Further, most health care facilities are accredited. HCFA rules governing appropriate use and accreditation standards for device use and personnel training provide the control necessary to ensure that the devices are used correctly. The application of these standards along with public awareness and health care provider training have contributed significantly to ensuring that the least restrictive restraint is used, that restraints are used only when needed for proper medical treatment, and that their use is under appropriate supervision.

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