leva Pelvic Digital Health System

GUDID 00860002994406

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 to transmit 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.

RENOVIA INC.

Perineometer
Primary Device ID00860002994406
NIH Device Record Key03a5254a-f640-4100-b310-7eb2bf6368f5
Commercial Distribution StatusIn Commercial Distribution
Brand Nameleva Pelvic Digital Health System
Version Model Numberleva-02
Company DUNS074563048
Company NameRENOVIA INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7637428227
Emailjhauge@renoviainc.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com
Phone855-538-2594
Emailsupport@levacares.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 0 KiloPascal and 70 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002994406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIRPerineometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-05
Device Publish Date2020-04-27

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