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Found 4 results
510(k) Data Aggregation
K Number
K063449Device Name
DELUXE NEBULIZER
Manufacturer
ACCESS POINT MEDICAL, L.L.C.
Date Cleared
2007-03-01
(106 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
ACCESS POINT MEDICAL, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Access Point, LLC Deluxe Nebulizer is intended to provide a source of compressed air for medical purposes for use in home health care. The Deluxe Nebulizer is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.
Device Description
The Deluxe Nebulizer, consist of four components. The nebulizer main unit, air compressor, air filters and nebulizer kit (hand held nebulizer with mouthpiece). The Nebulizer atomizes medicinal liquid into tiny fog droplets by compressing air. Patients inhale the compressed air for optimal internal medicinal delivery.
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K Number
K050279Device Name
AXS-1 LITE WHEELCHAIR
Manufacturer
ACCESS POINT MEDICAL, L.L.C.
Date Cleared
2005-04-11
(63 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
ACCESS POINT MEDICAL, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AXS-1 Lite Wheelchairs are indicated for providing mobility to persons limited to a sitting position
Device Description
The Access Point Medical Explorer Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical. steel frame and leatherette or nylon upholstery that meets FN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Access Point Medical Transport Series Transport Chair is intended for use indoors, over smooth Transport Series. Transport Chair is and China C standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater that 9 degrees.
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K Number
K050280Device Name
RUNABOUT WHEELCHAIR
Manufacturer
ACCESS POINT MEDICAL, L.L.C.
Date Cleared
2005-04-11
(63 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
ACCESS POINT MEDICAL, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AXS-1 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.
Device Description
The Access Point Medical AXS-1 Basic Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel frame and leatherette or nylon upholstery that meets EN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Access Point Medical Transport Series Transport Chair is intended for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater that 9 degrees.
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K Number
K050281Device Name
TRANSPORT SERIES TRANSPORT CHAIR
Manufacturer
ACCESS POINT MEDICAL, L.L.C.
Date Cleared
2005-04-11
(63 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
ACCESS POINT MEDICAL, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AXS Transport Chairs are indicated for providing mobility to persons limited to a sitting position
Device Description
The Access Point Medical AXS Transport Chair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of a rigid mechanical Aluminum Alloy or steel frame and nylon upholstery that meets EN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 8x1" solid rubber rear wheels and two 8x1" front casters for turning and maneuverability. The Access Point Medical Transport Series Transport Chair is intended for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater that 9 degrees.
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