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
Indications for 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
Submission Summary (Full Text)
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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.
