Intrelief PFE
Intrelief PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge…
Intrelief PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
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 | Easymed Instruments Co., Ltd., China |
|---|---|
| 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 |
| Record published | 2026-05-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Intrelief PFE | 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 |
|---|---|
| K241899 | 2024-11-27 |
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.