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Found 8 results
510(k) Data Aggregation
K Number
K091496Device Name
MEP-90 HAIR GROWTH STIMULATION SYSTEM
Manufacturer
MIDWEST R.F. LLC.
Date Cleared
2010-02-23
(279 days)
Product Code
OAP
Regulation Number
890.5500Why 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.
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K Number
K090267Device 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
892.1000Why 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
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K Number
K051618Device 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
892.1000Why 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
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K Number
K030317Device Name
MODEL 1300GE-64: PEDIATRIC POSITIONER
Manufacturer
MIDWEST R.F. LLC.
Date Cleared
2003-03-25
(54 days)
Product Code
MOS
Regulation Number
892.1000Why 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.
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K Number
K003097Device Name
BRAIN COIL, MODEL 9800GE-64
Manufacturer
MIDWEST R.F. LLC.
Date Cleared
2000-12-28
(86 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MIDWEST R.F. LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003386Device 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
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MIDWEST R.F. LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002860Device Name
MODEL 6900GE-64: C-SPINE ARRAY
Manufacturer
MIDWEST R.F. LLC.
Date Cleared
2000-11-22
(70 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MIDWEST R.F. LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002864Device Name
MODEL 6600GE-64: TRAMA NECK ARRAY
Manufacturer
MIDWEST R.F. LLC.
Date Cleared
2000-11-21
(69 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MIDWEST R.F. LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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