Who is the manufacturer of PEDIATRIC LIMB HOLDER?

Deroyal Industries, Inc. submitted the Traditional clearance for PEDIATRIC LIMB HOLDER (K963466).

What is the FDA product code for PEDIATRIC LIMB HOLDER?

FMQ. It is classified under 21 CFR 880.6760 as a Class 1 device in the General Hospital panel.

What is the regulatory pathway for PEDIATRIC LIMB HOLDER?

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

What are the predicate devices for PEDIATRIC LIMB HOLDER?

J.T. Posey Company (not specified); DeRoyal Industries, Inc. (not specified).

PEDIATRIC LIMB HOLDER

K963466 · Deroyal Industries, Inc. · FMQ · Feb 13, 1997 · General Hospital

Device Facts

Record ID	K963466
Device Name	PEDIATRIC LIMB HOLDER
Applicant	Deroyal Industries, Inc.
Product Code	FMQ · General Hospital
Decision Date	Feb 13, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6760
Device Class	Class 1
Attributes	Pediatric

Intended Use

The DeRoyal Industries, Inc. Pediatric Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient limb movements thereby enabling examination or protection of the patient or others. The Pediatric Limb Holder can be used with an OR table, gurney, bed, or stretcher.

Device Story

Protective restraint device; limits pediatric limb movement to facilitate medical examination or ensure safety. Comprised of polyester straps with hook and loop fasteners; foam padding (purr foam or kodel). Used in clinical settings (OR, gurney, bed, stretcher). Operated by healthcare professionals; requires physician prescription every 24 hours. Benefits include patient immobilization during procedures or to prevent self-injury.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: 100% polyester twill tape, white webbing, blue purr foam, white kodel. Fasteners: hook and loop. Sizes: infant, child, teen. Attachment: OR table, gurney, bed, stretcher.

Indications for Use

Indicated for pediatric patients requiring limb movement limitation for examination or protection of patient/others; use at discretion of licensed healthcare professional; applicable to infant, child, and teen populations.

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

J.T. Posey Company (not specified)
DeRoyal Industries, Inc. (not specified)

Related Devices

K963477 — PEDIATRIC MITTENS · Deroyal Industries, Inc. · Nov 12, 1996
K963387 — DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP · Morrison Medical Products · Nov 8, 1996
K963475 — PONCHO VEST RESTRAINT · Deroyal Industries, Inc. · Jan 22, 1997
K963476 — DISPOSABLE LIMB HOLDER · Deroyal Industries, Inc. · Jan 22, 1997
K963473 — REUSABLE LIMB HOLDER · Deroyal Industries, Inc. · Nov 14, 1996

Submission Summary (Full Text)

{0} K 963466 DeRoyal Industries, Inc. Pediatric Limb Holder FEB 13 1997 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. Pediatric Limb Holder COMMON/USUAL NAME: Pediatric Limb Holder 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. Pediatric Limb Holder is a protective restraint device that is intended for medical purposes to limit pediatric patient limb movements thereby enabling examination or protection of the patient or others. **Device Design/Materials Used/Physical Properties:** The DeRoyal Pediatric Limb Holder is designed similar to those marketed by other manufacturers. The Pediatric Limb Holder is primarily comprised of polyester straps with hook and loop fasteners. DEVICE INTENDED USE The DeRoyal Industries, Inc. Pediatric Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient limb movements thereby enabling examination or protection of the patient or others. The Pediatric Limb Holder can be used with an OR table, gurney, bed, or stretcher. TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S) | Characteristic | DeRoyal Device | Other Devices | | --- | --- | --- | | Materials | Primarily comprised of 100% polyester twill tape and white webbing. Materials also include blue purr foam or white kodel. Fasteners are made of hook and loop. | Same | | Size | Infant, child, teen | Same | | Vehicles for Attachment | OR Table, gurney, bed, or stretcher | Same | | Length of use | Doctor must prescribe every 24 hours | Same | | Level of Patient Activity | Limb Interference by Pediatric Patient | Same |