Who is the manufacturer of PONCHO VEST RESTRAINT?

Deroyal Industries, Inc. filed the 510(k) submission for PONCHO VEST RESTRAINT (K963475).

What is the FDA product code for PONCHO VEST RESTRAINT?

KID. It is classified under 21 CFR 890.3910 as a Class 1 device in the Physical Medicine panel.

What is the regulatory pathway for PONCHO VEST RESTRAINT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PONCHO VEST RESTRAINT?

J.T. Posey Company (unspecified 510(k)); DeRoyal Industries, Inc. (unspecified 510(k)).

Who can help prepare an FDA 510(k) submission like PONCHO VEST RESTRAINT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PONCHO VEST RESTRAINT

K963475 · Deroyal Industries, Inc. · KID · Jan 22, 1997 · Physical Medicine

Device Facts

Record ID	K963475
Device Name	PONCHO VEST RESTRAINT
Applicant	Deroyal Industries, Inc.
Product Code	KID · Physical Medicine
Decision Date	Jan 22, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.3910
Device Class	Class 1

Intended Use

The DeRoyal Industries, Inc. Poncho Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Poncho Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.

Device Story

Protective restraint device; limits patient movement to facilitate examination or ensure safety. Comprised of cool knit or cotton fabric with polyester straps; utilizes nylon hook and loop or steel nickel-plated buckles for fastening. Used in clinical settings (beds or wheelchairs) under supervision of licensed healthcare professionals. Device restricts patient mobility to prevent injury or interference with care; requires daily physician prescription.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: cotton flannel, polyester cool knit, nylon straps, steel nickel-plated buckles. Form factor: wearable vest in sizes X-Small through XXX-Large. Attachment: bed or wheelchair. Non-powered, mechanical restraint.

Indications for Use

Indicated for mildly agitated or disoriented patients requiring movement limitation for examination or protection of patient/others; used with bed or wheelchair; requires physician prescription every 24 hours.

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

J.T. Posey Company (unspecified 510(k))
DeRoyal Industries, Inc. (unspecified 510(k))

Related Devices

K963474 — TUXEDO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963469 — MITTENS · Deroyal Industries, Inc. · Nov 14, 1996
K963467 — ROLL BELTS · Deroyal Industries, Inc. · Jan 3, 1997
K963480 — MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER · Deroyal Industries, Inc. · Jan 22, 1997
K963470 — CRISS-CROSS VEST RESTRAINT · Deroyal Industries, Inc. · Nov 14, 1996

Submission Summary (Full Text)

{0} JAN 22 1997 X903475 # DeRoyal Industries, Inc. ## Poncho Vest Restraint ### 510(k) Summary ## SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED ### SUBMITTER INFORMATION **NAME:** DeRoyal Industries, Inc. **ADDRESS:** 200 DeBusk Lane Powell, TN 37849 **TELEPHONE:** (423) 938-7828 **CONTACT:** Camille Matlock **DATE OF PREPARATION:** August 30, 1996 ### DEVICE NAMES **NAME:** DeRoyal Industries, Inc. Poncho Vest Restraint **COMMON/USUAL NAME:** Poncho Vest Restraint **CLASSIFICATION NAME (if known):** Restraint, Protective (80FMQ) ### PREDICATE OR LEGALLY MARKETED DEVICES **J.T. Posey Company** DeRoyal Industries, Inc. ### DEVICE DESCRIPTION The DeRoyal Industries, Inc. Poncho Vest Restraint is a protective restraint device that is intended for medical purposes to limit movements thereby enabling examination or protection of the patient or others. **Device Design/Materials Used/Physical Properties:** The DeRoyal Poncho Vest Restraint is designed similar to those marketed by other manufacturers. The Poncho Restraint is primarily comprised of cool knit or cotton with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles. ### DEVICE INTENDED USE The DeRoyal Industries, Inc. Poncho Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Poncho Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair. ### TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S) | Characteristic | DeRoyal Device | Other Devices | | --- | --- | --- | | Materials | Primarily comprised of cotton flannel or polyester cool knit. The straps are made of polyester or nylon. Fasteners are made of hook and loop or steel nickel plated buckles. | Same | | Size | X-Small, Small, Medium, Large, X-Large, XX-Large, XXX-Large | Same | | Vehicles for Attachment | Bed or Wheelchair | Same | | Length of use | Doctor must prescribe every 24 hours | Same | | Level of Patient Activity | Mildly agitated or disoriented | Same |