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510(k) Data Aggregation
K Number
K121902Device Name
NATRATONE
Manufacturer
ORELLE CORPORATION LTD
Date Cleared
2013-06-06
(342 days)
Product Code
HIR
Regulation Number
884.1425Why did this record match?
Applicant Name (Manufacturer) :
ORELLE CORPORATION LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NatraTone® 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
NatraTone® is a pelvic floor muscle exerciser. It is a single, reusable device that comes into contact with the vaginal mucosal membrane for a limited (<24 hours) duration per each use. The device is 3.25 inches in length, 1.35 inch in width at its buibous base end and weighs 1 once or 28 grams. The registered trade name 'NatraTone' is embedded in the thumb-hold area of the device. The device is fully inserted to sit low in the vagina in contact with the perineal muscles.
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