Neocontrol Pelvic Floor Therapy System, Incontinence Treatment Device
The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic Hoor muscles for the treatment of stress, urge and…
The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic Hoor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women, helping with incontinence problems, Improve pelvic muscle strength. The device is supplied with a vaginally inserted electrodet,LCD Display,Comfortable treatment with 7 preset programs and intensity levels from 0 to 99.
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 | Blissco Medical Device Limited |
|---|---|
| FDA product code | KPI |
| Device type | Stimulator, Electrical, Non-Implantable, For Incontinence |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5320 |
| 510(k) | K001903 |
| Record published | 2024-11-14 |
| Record revised | 2025-04-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Distribution end date | 2025-04-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LT2061 | Withdrawn |
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
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.