Search Results
Found 10 results
510(k) Data Aggregation
K Number
K063328Device Name
IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)
Manufacturer
IMC-HEARTWAY, LLC
Date Cleared
2007-04-27
(175 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
IMC-HEARTWAY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Model-Allure (HP6), powered wheelchair is to provide mobility to adults, weighing up to 350 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.
Device Description
Not Found
Ask a Question
K Number
K063307Device Name
ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)
Manufacturer
IMC-HEARTWAY, LLC
Date Cleared
2007-02-27
(118 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
IMC-HEARTWAY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Rumba SR (P4R), is to provide mobility to adults weighing up to 300 Pounds and the ability to place themselves in a seated position on the chair and have the capacity to operate a standard joy stick hand control.
Device Description
Not Found
Ask a Question
K Number
K063320Device Name
ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)
Manufacturer
IMC-HEARTWAY, LLC
Date Cleared
2007-02-27
(117 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
IMC-HEARTWAY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Vision (P13) lift wheelchair is to provide forward and reverse mobility and up and down movement for greater accessibility to surroundings. This chair is designed for occupants weighing up to 350 pounds, whom have the capacity to operate a standard joy stick hand control.
Device Description
Not Found
Ask a Question
K Number
K063203Device Name
ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)
Manufacturer
IMC-HEARTWAY, LLC
Date Cleared
2007-02-13
(113 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
IMC-HEARTWAY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Rumba S (HP4) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.
Device Description
Not Found
Ask a Question
K Number
K063475Device Name
IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)
Manufacturer
IMC-HEARTWAY, LLC
Date Cleared
2007-01-23
(68 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
IMC-HEARTWAY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Model-Tiara (P4AS) powered wheelchair is to provide mobility to adults, weighing up to 300 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.
Device Description
Not Found
Ask a Question
K Number
K063474Device Name
ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)
Manufacturer
IMC-HEARTWAY, LLC
Date Cleared
2006-12-22
(36 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
IMC-HEARTWAY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Mini (P14) powered wheelchair is to provide a light weight chair with good maneuverability in and out of buildings. This chair is designed for occupants weighing up to 250 pounds, whom have the capacity to operate a standard joy stick hand control.
Device Description
Not Found
Ask a Question
K Number
K052008Device Name
IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7
Manufacturer
IMC-HEARTWAY, LLC
Date Cleared
2005-09-16
(53 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
IMC-HEARTWAY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the HP-7 provide mobility to adults limited to thing position that have the to operates a simple han Capa
Device Description
Model HP-7 Power Wheelchair
Ask a Question
K Number
K031897Device Name
PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
Manufacturer
IMC-HEARTWAY, LLC
Date Cleared
2003-09-23
(96 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
IMC-HEARTWAY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the PF-2 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.
Device Description
Model PF-2, Four Wheel Electric Scooter
Ask a Question
K Number
K030432Device Name
IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR
Manufacturer
IMC-HEARTWAY, LLC
Date Cleared
2003-05-01
(80 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
IMC-HEARTWAY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the IMC- Heartway Model HPS Wheelchair is to provide mobility to adults with the ability to place themselves or be placed in a sitting position and have the capacity to operate a simple hand control.
Device Description
Not Found
Ask a Question
K Number
K030427Device Name
HP-3 HD ELECTRIC WHEELCHAIR
Manufacturer
IMC-HEARTWAY, LLC
Date Cleared
2003-04-18
(67 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
IMC-HEARTWAY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the IMC-Heartway HP-3 HD wheelchair is to provide mobility to adults, limited to a sitting position and have the capability to operate a simple hand control.
Device Description
Model HP-3 HD Electric Wheelchair
Ask a Question
Page 1 of 1