Levina
Levina RS-48 is a non-implantable, home-use pelvic floor muscle stimulator. The filing describes electrical stimulation through an intravaginal probe to the pelvic floor muscles. Its stated…
Levina RS-48 is a non-implantable, home-use pelvic floor muscle stimulator. The filing describes electrical stimulation through an intravaginal probe to the pelvic floor muscles.
Its stated use is rehabilitation of weak pelvic floor muscles for stress, urge and mixed urinary incontinence in women, and to maintain urinary continence in women.
Listed Item
Levina Pelvic Floor Muscle Stimulator (RS-48)
Device Components
The supplied components include a remote control, a stimulator pod and a reusable single-patient-use vaginal stimulation probe. The pod has two output channels and applies electrical stimulation according to settings sent by the remote control.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Netop Industrial Company Limited | Dongguan | Guangdong | Manufacturer | 14 |
| Shenzhen Changkun Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shenzhen Konmed Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Easymed Instruments Co., Ltd. | Daliang, Shunde, Foshan | Guangdong | Contract manufacturer | 8 |
| Dolanvy (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | ZMI Electronics Ltd., Taiwan |
|---|---|
| FDA product code | KPI |
| Device type | Stimulator, Electrical, Non-Implantable, For Incontinence |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5320 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K241862 |
| Record published | 2026-04-14 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 2 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RS-48 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lifecare | Everyway Medical Instruments Co., Ltd. | 28 |
| EMC Evolution | EMC Evolution | 10 |
| Konmed | Shenzhen Konmed Technology Co., Ltd. | 8 |
| DLR | Dolanvy (Suzhou) Medical Technology Co., Ltd. | 8 |
| iSTIM | Everyway Medical Instruments Co., Ltd. | 7 |
| Pathway® | Prometheus Group OF NEW Hampshire Limited, THE | 6 |
| Everyway | Everyway Medical Instruments Co., Ltd. | 5 |
| Liberty | Utah Medical Products, Inc. | 4 |
| TensCare | Tenscare Ltd. | 4 |
| BTL Chair Applicator | Btl Industries, Ltd. | 3 |
| NeoControl | Magic Race LLC | 3 |
| Konmed /Pelvifine | Shenzhen Konmed Technology Co., Ltd. | 3 |
Showing 12 of 42. All products under Stimulator, Electrical, Non-Implantable, For Incontinence
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241862 | 2025-03-27 |
| K231166 | 2024-01-18 |
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.