ANALYTICA LTD

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Perineometer (HIR) (1)

Premarket Exempt

Clear

PeriCoach® - 09338067000581 Catalog Number : NA

Device Description : The PeriCoach is a perineometer designed to treat stress, mild-moderate urge and The PeriCoach 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. The PeriCoach® 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.

Device Class : 2

Duns Number: 753358829

Premarket Exempt : No

Product Code : HIR

Prescription Use : No

Device Count : 1

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