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510(k) Data Aggregation
K Number
K160758Device Name
PeriCoach OTC
Manufacturer
ANALYTICA LTD.
Date Cleared
2016-07-11
(115 days)
Product Code
HIR
Regulation Number
884.1425Why did this record match?
Applicant Name (Manufacturer) :
ANALYTICA LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PeriCoach® OTC is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.
Device Description
The PeriCoach® OTC device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of contraction of the user's pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device to be supplied over-the-counter.
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