Lifecare
28 catalogue numbers from PR-20H, listed by Everyway Medical Instruments Co., Ltd., Taiwan, 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
28catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Everyway Medical Instruments Co., Ltd., Taiwan |
|---|---|
| FDA product code | KPI |
| Device type | Stimulator, Electrical, Non-Implantable, For Incontinence |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5320 |
| Establishment | Manufacturer |
| 510(k) | K122194 |
| Record published | 2016-12-02 |
| Record revised | 2023-12-11 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PR-20H | In distribution | |
| PR-14H | In distribution | |
| PR-13A | In distribution | |
| PR-02V-2 | In distribution | |
| PR-06H | In distribution | |
| PR-10A | In distribution | |
| PR-03 | In distribution | |
| PR-14K | In distribution | |
| PR-11A | In distribution | |
| PR-06A | In distribution | |
| PR-04A | In distribution | |
| PR-02A-2 | In distribution | |
| PR-20K | In distribution | |
| PR-20A | In distribution | |
| PR-03A | In distribution | |
| PR-04 | In distribution | |
| PR-06 | In distribution | |
| PR-04K | In distribution | |
| PR-08A-1 | In distribution | |
| PR-03K | In distribution | |
| PR-06K | In distribution | |
| PR-03H | In distribution | |
| PR-02A | In distribution | |
| PR-12A | In distribution | |
| PR-02V-1 | In distribution | |
| PR-04H | In distribution | |
| PR-13 | In distribution | |
| PR-02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| BTL Emsella | Btl Industries, Ltd. | 2 |
Showing 12 of 42. All products under Stimulator, Electrical, Non-Implantable, For Incontinence
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213116 | 2021-12-03 |
| K122194 | 2013-04-04 |
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.