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.

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• Primary Device ID: 00860002994406
• NIH Device Record Key: 03a5254a-f640-4100-b310-7eb2bf6368f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: leva Pelvic Digital Health System
• Version Model Number: leva-02
• Company DUNS: 074563048
• Company Name: RENOVIA INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7637428227
• Email: jhauge@renoviainc.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com
• Phone: 855-538-2594
• Email: support@levacares.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal
• Storage Environment Temperature: Between 5 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 70 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002994406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192270
• Premarket Notification: K213913

FDA Product Code

• HIR: Perineometer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-05
• Device Publish Date: 2020-04-27