RENOVIA INC.

Address:263 Summer St,Boston,MA,02210,US

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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

leva Pelvic Digital Health System - 00860002994406 Catalog Number :

Device Description : The leva-02 PDHS is a prescription intra-vaginal device designed to allow the us The leva-02 PDHS is a prescription intra-vaginal device designed to allow the user (or woman) to rehabilitate and strengthen their pelvic floor muscles (PFM) as well as allow them to monitor their progress during pelvic floor muscle training (PFMT). The leva-02 is designed to wirelessly facilitate pelvic floor muscle training (PFMT) in women and totransmit real-time performance data through a dedicated mobile application that has been downloaded to the patient's mobile device. The leva-02 is designed to be used vaginally and is intended to be used repeatedly by a single patient.

Device Class : 2

Duns Number: 074563048

Premarket Exempt : No

Product Code : HIR

Prescription Use : Yes

Device Count : 1

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