Konmed
The Konmed Incontinence Stimulation Electrode filing names vaginal probe models KM-503, KM-504, KM-505, KM-506, KM-507 and KM-5013, and rectal probe models KM-502 and KM-5018. These probes…
The Konmed Incontinence Stimulation Electrode filing names vaginal probe models KM-503, KM-504, KM-505, KM-506, KM-507 and KM-5013, and rectal probe models KM-502 and KM-5018.
These probes provide electromyographic feedback from pelvic muscles or deliver electrical stimulation to pelvic muscles.
Stated Use
The filing describes their use in rehabilitation of weak pelvic floor muscles.
The FDA letter classifies the device as a Class II nonimplanted electrical continence device.
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 | Shenzhen Konmed Technology 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K233576 |
| Record published | 2024-03-05 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KM-505 | In distribution | |
| KM-502 | In distribution | |
| KM-507 | In distribution | |
| KM-506 | In distribution | |
| KM-5013 | In distribution | |
| KM-504 | In distribution | |
| KM-503 | In distribution | |
| KM-5018 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lifecare | Everyway Medical Instruments Co., Ltd. | 28 |
| EMC Evolution | EMC Evolution | 10 |
| 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 |
|---|---|
| K260178 | 2026-06-18 |
| K233576 | 2024-02-23 |
| K220161 | 2022-07-20 |
| K163288 | 2018-01-18 |
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.