EMC Evolution
10 catalogue numbers from 112-B0-1-S, listed by EMC Evolution, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
10catalogue numbers in this listing
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 | EMC Evolution |
|---|---|
| FDA product code | KPI |
| Device type | Stimulator, Electrical, Non-Implantable, For Incontinence |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5320 |
| 510(k) | K990041 |
| Record published | 2017-04-04 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 112-B0-1-S | In distribution | |
| 201-B0-1 | In distribution | |
| 103-P0-1 | In distribution | |
| 103-P1-1 | In distribution | |
| 203-P0-1 | In distribution | |
| 203-P0-1-S | In distribution | |
| 112-B0-1 | In distribution | |
| 105-P0-1 | In distribution | |
| 116-B0-1 | In distribution | |
| 105-P0-1-S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lifecare | Everyway Medical Instruments Co., Ltd. | 28 |
| 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 |
| BTL Emsella | Btl Industries, Ltd. | 2 |
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.