Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K091496
    Device Name
    MEP-90 HAIR GROWTH STIMULATION SYSTEM
    Manufacturer
    MIDWEST R.F. LLC.
    Date Cleared
    2010-02-23

    (279 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDWEST R.F. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MEP-90 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for: Medically prescribed use for the treatment of androgenic alopecia in females: The treatment of androgenic alopecia in females by promoting hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV.
    Device Description
    The MEP-90 is a stationary low-level laser device that promotes hair growth and provides treatment for androgenic (androgenetic) alopecia in females. The device provides automated and timed equal distribution of laser light to 100% of the scalp. The MEP-90 operation is controlled by an operating system that affords the user maximum flexibility for individual treatments. The device applies a measured very high tolerance (≤+.76%) wavelength (λ) to the scalp stimulating hair growth by the proven concept of biostimulation.
    Ask a Question
    K Number
    K090267
    Device Name
    SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64
    Manufacturer
    MIDWEST R.F. LLC.
    Date Cleared
    2009-03-16

    (41 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDWEST R.F. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 2D and 3D Magnetic Resonance Imaging of the anatomy of human head, brain and brain-stem. This device is used in conjunction with a Siemens Medical Systems 1.5 Tesla MRI Scanner with Total imaging matrix (Tim) option.
    Device Description
    SV Brain Array, Model# 1500SV-SMS64
    Ask a Question
    K Number
    K051618
    Device Name
    SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64
    Manufacturer
    MIDWEST R.F. LLC.
    Date Cleared
    2005-08-02

    (46 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDWEST R.F. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the anatomy of head and brain. This device is used in association with a General Electric 1.5T Signa MRI System and is currently cleared for use with the PROBE (Proton Brain Exam) option.
    Device Description
    Special Procedures II Head Coil, Model #1400GE-64
    Ask a Question
    K Number
    K030317
    Device Name
    MODEL 1300GE-64: PEDIATRIC POSITIONER
    Manufacturer
    MIDWEST R.F. LLC.
    Date Cleared
    2003-03-25

    (54 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDWEST R.F. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA) and Proton Spectroscopy of the pediatric head, body and extremities. This device is used in conjunction with a General Electric 1.5 Tesla MRI System. Proton Spectroscopy is used in conjunction with the PROBE (Proton Brain Exam) option.
    Device Description
    Model 1300GE-64 - Pediatric Positioner. Compatible with GE Signa 1.5T MRI Systems. MRI Accessory.
    Ask a Question
    K Number
    K003097
    Device Name
    BRAIN COIL, MODEL 9800GE-64
    Manufacturer
    MIDWEST R.F. LLC.
    Date Cleared
    2000-12-28

    (86 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDWEST R.F. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003386
    Device Name
    SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64
    Manufacturer
    MIDWEST R.F. LLC.
    Date Cleared
    2000-12-28

    (58 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDWEST R.F. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002860
    Device Name
    MODEL 6900GE-64: C-SPINE ARRAY
    Manufacturer
    MIDWEST R.F. LLC.
    Date Cleared
    2000-11-22

    (70 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDWEST R.F. LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002864
    Device Name
    MODEL 6600GE-64: TRAMA NECK ARRAY
    Manufacturer
    MIDWEST R.F. LLC.
    Date Cleared
    2000-11-21

    (69 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDWEST R.F. LLC.

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

    Page 1 of 1