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510(k) Data Aggregation

    K Number
    K070402
    Device Name
    MODIFICATION TO POLAR CARE 500
    Manufacturer
    BREG, INC.
    Date Cleared
    2007-03-29

    (45 days)

    Product Code
    ILO
    Regulation Number
    890.5720
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREG, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Local anesthetic effect which significantly reduces pain . following an injury, surgery or rehabilitative therapy - Early use of cold therapy following an injury or surgery will ● reduce primary bleeding and swelling - Temporary decrease in blood circulation, where applied, . reduces pain and swelling.
    Device Description
    Not Found
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    K Number
    K041714
    Device Name
    E-PAIN CARE
    Manufacturer
    BREG, INC.
    Date Cleared
    2004-10-01

    (100 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREG, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BREG's e-PAIN CARETM is intended to provide infusion of a 'local anesthetic into an intra-operative site for the post-operative management of pain.
    Device Description
    Not Found
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    K Number
    K020988
    Device Name
    PAIN CARE 4200
    Manufacturer
    BREG, INC.
    Date Cleared
    2002-04-04

    (8 days)

    Product Code
    MEB
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREG, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pain Care™ 4200 is indicated to provide continuous infusion for the post-operative management of pain.
    Device Description
    Not Found
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    K Number
    K013928
    Device Name
    PAIN CARE 3200
    Manufacturer
    BREG, INC.
    Date Cleared
    2001-12-03

    (5 days)

    Product Code
    MEB
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREG, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BREG's Pain Care 3200 has the same intended use as BREG's Pain Care 3000. Both units are intended to provide continuous infusion of a local anesthetic into an intra-operative site for the post-operative management of pain. The purpose of BREG's Pain Care 3000 and 3200 is to provide a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).
    Device Description
    Not Found
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    K Number
    K003611
    Device Name
    PAIN CARE MULTI-PORT CATHETER, MODEL 2000L
    Manufacturer
    BREG, INC.
    Date Cleared
    2000-12-13

    (21 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREG, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002073
    Device Name
    PAIN CARE 3000
    Manufacturer
    BREG, INC.
    Date Cleared
    2000-09-19

    (71 days)

    Product Code
    MEB
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREG, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002321
    Device Name
    PAIN CARE 2000L
    Manufacturer
    BREG, INC.
    Date Cleared
    2000-08-14

    (14 days)

    Product Code
    MEB
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREG, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983454
    Device Name
    PAIN CARE 2000
    Manufacturer
    BREG, INC.
    Date Cleared
    1998-12-16

    (77 days)

    Product Code
    MEB
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREG, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BREG's Pain Care 2000 is intended to provide patient controlled intermittent infusion of a local anesthetic into an intra-operative site for the post-operative management of pain. BREG's Pain Care 2000 provides a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).
    Device Description
    Not Found
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    K Number
    K963596
    Device Name
    POLAR CARE 300
    Manufacturer
    BREG, INC.
    Date Cleared
    1996-12-04

    (86 days)

    Product Code
    ILO
    Regulation Number
    890.5720
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREG, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961855
    Device Name
    POLAR CARE (MODEL 500/50000)
    Manufacturer
    BREG, INC.
    Date Cleared
    1996-08-09

    (87 days)

    Product Code
    ILO
    Regulation Number
    890.5720
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREG, INC.

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