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510(k) Data Aggregation
K Number
K171896Device Name
Feminine Personal Trainer (FPT)
Manufacturer
Ralston Group
Date Cleared
2017-08-29
(64 days)
Product Code
HIR
Regulation Number
884.1425Why did this record match?
Applicant Name (Manufacturer) :
Ralston Group
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Feminine Personal Trainer (FPT) is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.
Device Description
The FPT is designed specifically for women for their use in strengthening the pelvic floor musculature. It is a single, reusable, home-use device that comes into contact with the vaginal mucosal membrane for a limited (< 24 hours) duration per each use. The FPT is an hourglass-shaped device made from surgical stainless steel. The FPT is available in three sizes: standard, small and petite. The FPT is inserted into the vagina and is held in place by contracting the pelvic floor muscles. The hourglass shape ensures automatic positioning so that the appropriate muscles are targeted. The weight of the FPT provides resistance as it is gently lifted with each contraction of the pelvic floor muscles. When utilized correctly, the device will move upward and inward when the user contracts her pelvic floor muscles. The body's angle while exercising controls the level of resistance.
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