Identity
- Trade Name
- Leva Pelvic Health System FDA UDI
- Generic Name
- Perineometer FDA UDI
- Device Name
- The Leva Pelvic Health System (“Leva PHS” or “Leva System”) is a prescription intra-vaginal device designed to allow the user 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 system is designed to wirelessly facilitate PFMT in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded onto the patient’s mobile device. The Leva system is designed to be used vaginally and is intended to be used repeatedly by a single patient. FDA UDI
- Model / Reference
- Leva-02 FDA UDI
- Description
- The Leva Pelvic Health System (“Leva PHS” or “Leva System”) is a prescription intra-vaginal device designed to allow the user 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 system is designed to wirelessly facilitate PFMT in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded onto the patient’s mobile device. The Leva system is designed to be used vaginally and is intended to be used repeatedly by a single patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860002994406 FDA UDI
- 510(k) Number
- K213913 FDA UDI
- FDA Product Code
- HIR FDA UDI
- GMDN Term
- Perineometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Perineometer
Leva Pelvic Health System by Axena Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Axena Health, Inc.
Sources (1)
- FDA UDI 03a5254a-f640-4100-b310-7eb2bf6368f5 36 fields · synced May 30, 2026