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510(k) Data Aggregation
K Number
K122800Device Name
INNER PEACE
Manufacturer
Date Cleared
2013-10-04
(387 days)
Product Code
Regulation Number
884.1425Why did this record match?
Applicant Name (Manufacturer) :
KAMABRY, INC., DBA INNER PEACE FOR WOMEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Inner Peace™ pelvic exercise device is recommended for the strengthening of perineal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.
Device Description
Inner Peace™ is a one-piece, silicone intravaginal pelvic-floor exercise device that squeezes down to be easily inserted, only to spring back to its original shape to fit comfortably and snugly against the vaginal walls. The enclosed spring provides resistance as the User performs kegel exercises to strengthen and tone the pelvic floor muscles
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