Leva Pelvic Health System
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)…
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.
Who Else Makes It
Concentrated in Guangdong (4), Shanghai (1), Hunan (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Dongguan Q & S Electronic Manufacturing Company Limited | Dongguan | Guangdong | Contract manufacturer | 5 |
| Suzhou Armocon Technology Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 5 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Shenzhen Konmed Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Hunan Accurate BIO-Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 7 |
| Guangdong Yuxiang Silicone & Plastic Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 2 |
Record
| Listed by | Axena Health, Inc., United States |
|---|---|
| FDA product code | HIR |
| Device type | Perineometer |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1425 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K213913 |
| Record published | 2020-04-27 |
| Record revised | 2023-10-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 70 °C; Storage environment humidity 0 to 90 % RH; Storage environment atmospheric pressure up to 70 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Leva-02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pathway | Prometheus Group OF NEW Hampshire Limited, THE | 7 |
| Peritron | Laborie Medical Technologies, Canada ULC | 4 |
| Perifit Care+ | X6 Innovations | 3 |
| Levina | ZMI Electronics Ltd. | 3 |
| Flyte In-Home Pelvic Floor Treatment | Pelvital USA, Inc. | 2 |
| MEP | Personal Medical Corp. | 2 |
| Perifit | X6 Innovations | 2 |
| IVS-2 | Personal Medical Corp. | 2 |
| FemiScan | Bittium Biosignals Ltd. | 2 |
| SenseRx — Anal/Small Vaginal and Vaginal EMG | Personal Medical Corp. | 2 |
| Intimate Rose | Plus EV Holdings Inc | 1 |
| InTone® Nasp | Incontrol Medical, LLC | 1 |
Showing 12 of 36. All products under Perineometer
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.