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510(k) Data Aggregation

    K Number
    K022652
    Device Name
    ALPHATRAC, MODEL A 205
    Manufacturer
    Date Cleared
    2002-11-21

    (104 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEFTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for use for the Model A205 AlphaTrac® Powered Wheelchair base: AlphaTrac® design definitions and functional parameters are indicated for usage for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gait patterns. Also, due to the specific driving control supplied by the transaxle, persons with spasticity or ataxic movements in their extremity's that are not candidates for other types of mobility without extensive modification may be appropriate for the AlphaTrace with no modifications. This usage would be indicated but not limited to the following types of injury's: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Brown Sequard's Syndrome Severe Arthritics (RA) (OA) Multiple Sclerosis Huntington's Corea Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Anoxic Encephalopathy Anoxia Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) Quadriparesis Obesity Parkinson's This is not meant to be an all-inclusive list, anyone needing power assistance with their mobility may be an appropriate client for a AlphaTrac powered wheelchair. This would usually be decided by clinical evaluation of the client's strength, sitting balance, mobility needs, size constraints and driving capability at their local rehab facility.
    Device Description
    Not Found
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    K Number
    K013307
    Device Name
    OMEGATRAC, MODEL Z105
    Manufacturer
    Date Cleared
    2002-02-08

    (127 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEFTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for use for the Model Z105 ΩmegaTrac® Powered Wheelchair base: IntegaTract design definitions and functional parameters are indicated for usage for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gait patterns. Also, due to the specific driving control supplied by the transaxle, persons with spasticity or ataxic movements in their extremity's that are not candidates for other types of mobility without extensive modification may be appropriate for the SmegaTrac® with no modifications. This usage would be indicated but not limited to the following types of injury's: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Brown Sequard's Syndrome Severe Arthritics (RA) (OA) Multiple Sclerosis Huntington's Corea Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Anoxic Encephalopathy Anoxia Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) Quadriparesis Obesity Parkinson's This is not meant to be an all-inclusive list, anyone needing power assistance with their mobility may be an appropriate client for an QmegaTrac® powered wheelchair. This would usually be decided by clinical evaluation of the client's strength, sitting balance, mobility needs, size constraints and driving capability at their local rehab facility.
    Device Description
    Model Z105 Ωmega Trac® Powered Wheelchair
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    K Number
    K993160
    Device Name
    OMEGA TRAC, MODEL Z100
    Manufacturer
    Date Cleared
    1999-11-18

    (58 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEFTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for use for the ΩmegaTrac® Powered Wheelchair base: ΩmegaTrac® design definitions and functional parameters are indicated for usage for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gait patterns. Also, due to the specific driving control supplied by the transaxle, persons with spasticity or ataxic movements in their extremity's that are not candidates for other types of mobility without extensive modification may be appropriate for the ΩmegaTrac® with no modifications. This usage would be indicated but not limited to the following types of injury's: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Brown Sequard's Syndrome Severe Arthritics (RA) (OA) Multiple Scierosis Huntington's Corea Traumatic Brain Injury (TBI) Amyotrophic Lateral Scierosis (ALS) Anoxic Encephalopathy Anoxia Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) Quadriparesis Obesity Parkinson's This is not meant to be an all-inclusive list, anyone needing power assistance with their mobility may be an appropriate client for an ΩmegaTrac® powered wheelchair. This would usually be decided by clinical evaluation of the client's strength, sitting balance, mobility needs, size constraints and driving capability at their local rehab facility.
    Device Description
    Not Found
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    K Number
    K992627
    Device Name
    FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500
    Manufacturer
    Date Cleared
    1999-10-25

    (81 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEFTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TEFTEC Corporation FirstClass™ Power Recline Seating System has been designed for use by anyone needing pressure relief while in a seated position. The FirstClass™ Power Recline Seating System could provide pressure relief by postural change for persons having the following condition or injury: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Hyper Reflexia Chronic Pain Burn Trauma Patient Severe Scar Tissue build up Brown Sequard's Syndrome Multiple Sclerosis Heterotrophic Ossification Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Quadriplegia Cerebral Palsy Paraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) This is not meant to be an all-inclusive list, anyone needing pressure relief or positional change that is unable to facilitate those movements independently would be able to accomplish them with this unit. This would usually be decided by clinical evaluation of the client's strength, sensation level, upper extremity strength, mobility needs and seating needs.
    Device Description
    FirstClass™ Power Recline Seat System Model S500
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    K Number
    K992628
    Device Name
    FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400
    Manufacturer
    Date Cleared
    1999-10-25

    (81 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEFTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TEFTEC Corporation FirstClass™ Power Tilt & Recline Seating System has been designed for use by anyone needing pressure relief while in a seated position. The FirstClass™ Power Tilt & Recline Seating System could provide pressure relief by postural change for persons having the following condition or injury: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Hyper Reflexia Chronic Pain Burn Trauma Patient Severe Scar Tissue build up Brown Sequard's Syndrome Multiple Sclerosis Heterotrophic Ossification Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Quadriplegia Cerebral Palsy Paraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) This is not meant to be an all-inclusive list, anyone needing pressure relief or positional change that is unable to facilitate those movements independently would be able to accomplish them with this unit. This would usually be decided by clinical evaluation of the client's strength, sensation level, upper extremity strength, mobility needs and seating needs.
    Device Description
    Not Found
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    K Number
    K983066
    Device Name
    FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300
    Manufacturer
    Date Cleared
    1998-11-27

    (86 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEFTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TEFTEC Corporation FirstClass™ Power Tilt Seating System has been designed for use by anyone needing pressure relief while in a seated position. The First Class™ Power Tit Seating System could provide pressure relief by postural change for persons having the following condition or injury: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Hyper Reflexia Chronic Pain Burn Trauma Patient Severe Scar Tissue build up Brown Sequard's Syndrome Multiple Scierosis Heterotrophic Ossification Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Quadriplegia Cerebral Palsy Paraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) This is not meant to be an all-inclusive list. Anyone needing pressure relief or positional change that is unable to facilitate those movements independently, would be able to accomplish them with this unit. This would usually be decided by clinical evaluation of the client's strength, sensation level, upper extremity strength, mobility needs and seating needs.
    Device Description
    FirstClass™ Powered Tilt Seat System, Model S300
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    K Number
    K982815
    Device Name
    ALPHATRAC, MODEL A200
    Manufacturer
    Date Cleared
    1998-11-06

    (87 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEFTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Indications for use for the Alpha Trac powered wheelchair base: Alpha Trac design definitions and functional parameters are indicated for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gail patterns. Also due to the specific driving control supplied by the TransAxle persons with spasticity or ataxic movements in their extremity's that are not candidates for other types of mobility without extensive modification may be appropriate for the AlphaTrac with no modifications. This usage would be indicated but not limited to the following types of injury's: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Parkinson's Amputees Brown Sequard's Syndrome and resultant paralysis Severe Arthritics (RA) (OA) Multiple Sclerosis (MS) Amyotrophic Lateral Sclerosis (ALS) Huntington's Corea Traumatic Brain Injury (TBI) Anoxic Encephalopathy Anoxia Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal weakness Quadriparesis Paranaresis Cercural vascular Accident (C < H or Stroke) This is not meant to be an all inclusive list, anyone needing power assistance with their mobility may be an appropriate client for an AlphaTrac powered wheelchair. This would usually be decided by clinical evaluation of the client's strength sitting balance, mobility needs, size constraints and driving capability at their local rehab facility.
    Device Description
    AlphaTrac™ Powered Wheelchair
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    K Number
    K955240
    Device Name
    OMEGATRAC BY TEFTEC
    Manufacturer
    Date Cleared
    1996-07-01

    (230 days)

    Product Code
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEFTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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