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510(k) Data Aggregation
K Number
K021115Device Name
GYNEFLEX
Manufacturer
NAISSANCE HOLDINGS, LC
Date Cleared
2002-12-20
(256 days)
Product Code
HIR
Regulation Number
884.1425Why did this record match?
Applicant Name (Manufacturer) :
NAISSANCE HOLDINGS, LC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GyneFlex is recommended for the strengthening of the perineal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence.
Device Description
The GyneFlex is a pelvic floor muscle exerciser. The product has six ranges of resistance. Other than variation in resistance, each exerciser is identical, including identical indications and labeling. It is a "v" sh aped device that provides resistance after insertion into the vagina when the patient contracts her pelvic muscles. The material is made of a polymer plastic specifically formulated to provide specific ranges of resistance for use as an adjunct to Kegel exercises.
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