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510(k) Data Aggregation
K Number
K050508Device Name
HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
Manufacturer
HAYWOOD VOCATIONAL OPPORTUNITIES
Date Cleared
2005-04-27
(58 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
HAYWOOD VOCATIONAL OPPORTUNITIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HVO surgical drapes are made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. They are designed to be repackaged and/or sterilized before use. This single use product is a disposable non-sterile drape designed to be re-packaged and/or sterilized prior to use. This product may be sterilized using Ethylene Oxide (EO) following the Validation and Routine Control under ANSI/AMMI/ISO 11135. For more information about sterilization of this product, contact HVO, Inc.
Device Description
The proposed HVO, Inc. Various Disposable Non-Sterile Surgical Drapes function in the same manner as predicate devices in that they are intended to be used as protective patient coverings, such as used to isolate a site of surgical incision from microbial and other contamination. Device Design/ Materials Used/ Physical Properties: The HVO, Inc. Various Disposable Non-Sterile Surgical Drapes are made of materials commonly used for their purpose. The primary material components are SMS, Micro-embossed LDPE, Clear LDPE, Nonwoven (wetlaid cellulose), Airtex, Sontara, Krayton, Medical Grade Single and Double Coated Tapes, Bridging, Polyfoam, Velcro, Polyester Mesh, Hot Melt, Cold Glue and Coated Medical Grade Liners. Primarily all of our drapes are offered in the color blue, which is the common color for medical device materials, but some materials are offered in white or with white backing. These materials include Nonwovens, SMS, Airtex, Sontara, Polyfoam, Back Table Covers, Bridging, and LDPE's. All other materials are clear plastics or adhesives, which are not colored, but natural.
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K Number
K023005Device Name
AQUILLA MODULAR WHEELCHAIR
Manufacturer
HAYWOOD VOCATIONAL OPPORTUNITIES
Date Cleared
2002-10-18
(39 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
HAYWOOD VOCATIONAL OPPORTUNITIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aquilla Modular Wheelchair is intended to provide mobility for occupants who are unable to walk or have difficulty in walking without assistance.
Device Description
The Aquilla Modular Wheelchair is manually operated, and can be configured for propulsion by an attendant or an occupant. The range of sizes and build configurations are suitable for male or female sizes from junior to adult. The Aquilla Modular Wheelchair consists of typical components found on most manual wheelchairs. The chairs feature a backrest, folding seat frame, footrest, rear wheels and front castors. Accessories include occupant-positioning belts, and optional features which allow a chair to be changed simply to meet the changing environmental and health requirements of the occupant. Aquilla is suitable for use both indoors and outdoors on surfaces that are intended typically for public access. This type of wheelchair is not suitable for soft and undulating terrain or for climbing obstacles. Aquilla can be easily folded for compact storage, and armrests and footrests can be removed to reduce the weight for lifting. Aquilla is labeled to indicate important aspects of use, including warnings and cautions.
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