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Found 7 results
510(k) Data Aggregation
K Number
K140023Device Name
ELEVATION
Manufacturer
PDG PRODUCT DESIGN GROUP, INC.
Date Cleared
2014-10-16
(283 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated position.
Device Description
The PDG Product Design Group, Inc. Elevation Manual Wheelchair (Elevation) is a manually operated, user propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons ages 12 and up (adolescents and adults) limited to a seated position. It is an ultra-light, rigid (non-folding frame) type wheelchair.
The device consists primarily of a lower frame assembly, a seat sling, a back rest and back upholstery, large rear wheels with hand rims for self-propelling the chair and front swivel type pivoting casters for turning.
The Elevation also has seat height and back rest recline angle adjustment capability that allow the user to self-adjust either the seat to floor height or the back rest recline angle while seated in the wheelchair. The Elevation is capable of up to 5 inches of rear to front seat height difference.
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K Number
K063736Device Name
FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50
Manufacturer
PDG PRODUCT DESIGN GROUP, INC.
Date Cleared
2007-01-17
(30 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide mobility to persons limited to a seated position.
Device Description
The PDG Models Fuze T20 and T50 wheelchairs are manually operated, self propelled mechanical wheelchairs. Their intended function and use is to provide mobility to persons that may be limited to a seated position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.
Both wheelchairs include a tilt mechanism which allows the upper frame of the wheelchair to be tilted. This feature is used to provide pressure relief as well as comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.
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K Number
K061475Device Name
ASTROTILT MANUAL WHEELCHAIR
Manufacturer
PDG PRODUCT DESIGN GROUP, INC.
Date Cleared
2006-06-14
(15 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide mobility to individuals limited to a sitting position.
Device Description
Not Found
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K Number
K990557Device Name
THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR
Manufacturer
PDG PRODUCT DESIGN GROUP, INC.
Date Cleared
1999-03-22
(28 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the device is in providing mobility to persons restricted to a sitting position.
Device Description
The Stellar Tilt, Manually Operated Wheelchair
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K Number
K971389Device Name
ECLIPSE 400 MANUALLY OPERATED WHEELCAIR
Manufacturer
PDG PRODUCT DESIGN GROUP, INC.
Date Cleared
1997-05-09
(25 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970311Device Name
BENTLEY MANUALLY OPERATED WHEELCHAIR
Manufacturer
PDG PRODUCT DESIGN GROUP, INC.
Date Cleared
1997-02-14
(18 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961743Device Name
ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR
Manufacturer
PDG PRODUCT DESIGN GROUP, INC.
Date Cleared
1996-05-29
(26 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PDG PRODUCT DESIGN GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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