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510(k) Data Aggregation
K Number
K091482Device Name
HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4
Manufacturer
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD
Date Cleared
2009-07-06
(48 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
**DANYANG HUAYI MEDICAL SUPPLY **& EQUIPMENT CO, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications Huayi K3/K4 lightweight wheelchair is indicated for providing mobility to persons limited to a sitting position.
Device Description
The Danyang Huayi K3/k4 wheelchair is a lightweight wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel and aluminum frame and nylon upholstery back and seat that meet ISO 7176-16: Resistance to ignition of Upholstered parts. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Danyang Huayi K3/K4 wheelchair is intended for the use in indoors and outdoors, over smooth surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that free of large obstacles and inclines greater than 9 degrees.
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K Number
K080207Device Name
DANYANG HUAYI K2 AND K7 WHEELCHAIRS
Manufacturer
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD
Date Cleared
2008-03-12
(44 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
**DANYANG HUAYI MEDICAL SUPPLY **& EQUIPMENT CO, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Danyang Huayi® K7 Wheelchair is indicated for providing mobility to persons limited to a sitting position.
Device Description
The Danyang Huayi K7 wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid. mechanical, steel frame and nylon upholstery back and seat that meet ISO 7176-16: Resistance to ignition of Upholstered parts. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Danyang Huavi K7 wheelchair is intended for the use in indoors and outdoors, over smooth surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that free of large obstacles and inclines greater than 9 degrees.
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K Number
K080114Device Name
HUAYI H035 BASIC WHEELCHAIR
Manufacturer
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD
Date Cleared
2008-02-15
(30 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
**DANYANG HUAYI MEDICAL SUPPLY **& EQUIPMENT CO, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Danyang Huayi® H035 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.
Device Description
The Danyang Huayi H035 Basic Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel frame and nylon upholstery that meets ISO 7176-16: Resistance to ignition of Upholstered parts. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Danyang Huayi H035 wheelchair is intended for use indoors and outdoors, over smooth a surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 9 degrees.
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