Who is the manufacturer of VOLLMAN PRONE POSITIONER?

Hill-Rom, Inc. filed the 510(k) submission for VOLLMAN PRONE POSITIONER (K963091).

What is the FDA product code for VOLLMAN PRONE POSITIONER?

IPT. It is classified under 21 CFR 890.3490 as a Class 1 device in the Physical Medicine panel.

What is the regulatory pathway for VOLLMAN PRONE POSITIONER?

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

What are the predicate devices for VOLLMAN PRONE POSITIONER?

Stryker Circ-O-lectric Bed Model 460; Stryker Wedge Turning Frame Model 965.

Who can help prepare an FDA 510(k) submission like VOLLMAN PRONE POSITIONER?

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.

VOLLMAN PRONE POSITIONER

K963091 · Hill-Rom, Inc. · IPT · Jan 9, 1997 · Physical Medicine

Device Facts

Record ID	K963091
Device Name	VOLLMAN PRONE POSITIONER
Applicant	Hill-Rom, Inc.
Product Code	IPT · Physical Medicine
Decision Date	Jan 9, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.3490
Device Class	Class 1
Attributes	Therapeutic

Intended Use

To assist caregivers in turning patients to or from the supine or prone position. Turning immobile patients can assist in treating pulmonary complications or disorders commonly associated with immobility.

Device Story

Non-powered, portable accessory for hospital beds; enables transition of immobile patients with respiratory complications (e.g., ARDS) between supine and prone positions. Operated by three caregivers; device secures patient via straps/padded surfaces while on existing hospital frame or therapeutic air support surface. Replaces manual lifting; facilitates pulmonary care; reduces caregiver physical strain.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metal frame construction; manual operation; non-powered; portable accessory form factor; designed for use with standard med-surg or critical care hospital beds with flat surfaces.

Indications for Use

Indicated for immobile patients requiring assistance with turning to or from supine or prone positions to treat pulmonary complications or disorders associated with immobility.

Regulatory Classification

Identification

A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

Predicate Devices

Stryker Circ-O-lectric Bed Model 460
Stryker Wedge Turning Frame Model 965

Related Devices

K973624 — NURSE'S AID PATIENT ROTATION SYSTEM · Air Med Assist Products · Jan 21, 1998
K102236 — HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P · D.T. Davis Enterprises Ltd. T/A Hovertech Int'L · Nov 18, 2010
K960188 — PRESSUREGUARD: SELECTCARE · Span-America Medical Systems, Inc. · Oct 2, 1996
K121287 — HT-WEDGE · D.T. Davis Enterprises Ltd. T/A Hovertech Int'L · Oct 3, 2012
K955243 — BARIAIR · Kinetic Concepts, Inc. · Oct 23, 1997

Submission Summary (Full Text)

{0} Vollman Prone Positioner 510(k) 1/2/96 K963091 # 15 510(k) Summary This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. 1. Submitted by: Hill-Roma, Inc 4349 Corporate Road Charleston, SC 29405 JAN - 9 1997 Contact Person: Edwin Bills Phone: (803)740-8380 Fax: (803)740-8059 2. Name of Device: Trade Name: Vollman Prone Positioner Common Name: Patient Positioner Classification Name: Manual Patient Rotation Bed 3. Predicate Device: Stryker Circ-O-lectric Bed Model 460 Preamendment Device Stryker Wedge Turning Frame Model 965 Preamendment Device 4. Description: The Vollman Prone Positioner Device is an independent, non-powered, portable accessory to any med-surg or critical care hospital bed with a flat surface that allows an immobile patient with respiratory complications, such as Acute Respiratory Distress Syndrome (ARDS) to be moved from a supine position to a prone position and held there. This position change occurs while the patient remains on either a regulation hospital frame (critical care or med-surg frame) or a therapeutic air support surface. This device allows this position change to be accomplished in most cases with only three caregivers. Currently, the most common method of proning a patient is manually lifting the patient and placing them prone. Other methods of proning a patient are the Stryker Wedge Turning Frame and the Stryker Circ-O-lectric Bed. 5. Intended Use: To assist caregivers in turning patients to or from the supine or prone position. Turning immobile patients can assist in treating pulmonary complications or disorders commonly associated with immobility. 6. Technological Characteristics: All of these devices have metal frames. In each device, the patient is held in place by a manual device such as a strap or padded surface. The Stryker Wedge Turning Frame and the Vollman Prone Positioner are manually-operated devices. The Stryker products have mattresses, where the subject device is an accessory to med-surg and critical care hospital beds with flat mattress surfaces.