Duns Number:074563048
Device Description: The leva-02 PDHS is a prescription intra-vaginal device designed to allow the user (or wom 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.
Catalog Number
-
Brand Name
leva Pelvic Digital Health System
Version/Model Number
leva-02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192270
Product Code
HIR
Product Code Name
Perineometer
Public Device Record Key
03a5254a-f640-4100-b310-7eb2bf6368f5
Public Version Date
May 05, 2020
Public Version Number
1
DI Record Publish Date
April 27, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |