Data / Medical devices / China / Shenzhen Konmed Technology Co., Ltd
Shenzhen Konmed Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 5 510(k) clearances
Shenzhen Konmed Technology Co., Ltd is registered with the FDA (registration 3011905669) in Shenzhen Guangdong, China. It lists 8 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 18, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011905669
- Address
- 601, Building B4, Shenchengtou creative factory life science park, Julongshan A Road, Xiuxin block Kengzi Street, Pingshan District, Shenzhen Guangdong, China, 518118
- Owner or operator
- Shenzhen Konmed Technology Co., Ltd (10054707)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- June 2, 2017
- Registered through
- 2026
- Brand names listed
- Biofeedback Nerve and Muscle Stimulator (Models: KM530B, KM531B, KM536, KM537), Electrode Lead Wires, Electrodes with silver conductive, Incontinence Stimulation Electrode (Rectal Probe: KM-502, KM-5018), Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013), Mouth to mouth shield Mouthpiece CPR Mask KM-110 KM-101 KM-102, Pelvic Muscle Trainer, Pelvic Muscle Trainer (KM510, KM516B) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Device, Biofeedback | HCC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Contract manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Perineometer | HIR | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Vibrator For Therapeutic Use, Genital | KXQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 2026 | K260178 | Pelvic Muscle Trainer (KM510, KM516B) | KPI | Substantially Equivalent | Shenzhen Konmed Technology Co., Ltd. | accessdata.fda.gov |
| February 23, 2024 | K233576 | Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) | KPI | Substantially Equivalent | Shenzhen Konmed Technology Co., Ltd. | accessdata.fda.gov |
| July 20, 2022 | K220161 | Biofeedback Nerve and Muscle Stimulator | KPI | Substantially Equivalent | Shenzhen Konmed Technology Co., Ltd. | accessdata.fda.gov |
| December 8, 2020 | K202648 | Biofeedback Nerve and Muscle Stimulator | IPF | Substantially Equivalent | Shenzhen Konmed Technology Co., Ltd. | accessdata.fda.gov |
| January 18, 2018 | K163288 | Pelvifine Pelvic Muscle Trainer | KPI | Substantially Equivalent | Shenzhen Konmed Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
- All makers of Perineometer
- All makers of Cable, Electrode
- All makers of Mouthpiece, Breathing
- All makers of Device, Biofeedback
Updated June 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.