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K Number
K033256Device Name
ATHENA PELVIC MUSCLE TRAINER II
Manufacturer
ATHENA FEMININE TECHNOLOGIES, INC.
Date Cleared
2003-12-30
(82 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
ATHENA FEMININE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Athena Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.
Device Description
The Athena Pelvic Muscle Trainer is a vaginal two electrode stimulation probe operale one in escripted Description of the Device. The Atlena Perio Missic Trans 15 a raginal vide of the remote control and is activated upon removal from the cradle.
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K Number
K023905Device Name
ATHENA PELVIC MUSCLE TRAINER
Manufacturer
ATHENA FEMININE TECHNOLOGIES, INC.
Date Cleared
2003-04-30
(159 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
ATHENA FEMININE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Athena Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.
Device Description
The Athena Pelvic Muscle Trainer is a vaginal two electrode stimulation probe operated through a FM remote control device. The probe is stored in an activator box that turns the probe on automatically when the probe is removed from the box.
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