Shenzhen Konmed Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 8 device types, 15 products catalogued, 7 clearances.
Shenzhen Konmed Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Perineometer, Cable, Electrode and 6 other device types. 15 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
8device types registered with the FDA
15products catalogued under its own name
7510(k) clearances
Registration
| Registered name | SHENZHEN KONMED TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011905669 |
| FEI number | 3011905669 |
| DUNS | 544436531 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市康美生科技有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 601, Building B4, Shenchengtou creative factory life science park, Julongshan A Road, Xiuxin block |
| Postal code | 518118 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cable, Electrode | Class 2 | Electrode Lead Wires | 2026 | 47 |
| Device, Biofeedback | Class 2 | Biofeedback Nerve and Muscle Stimulator (Models: KM530B, KM531B, KM536, KM537), Stimulator | 2020 | 6 |
| Electrode, Cutaneous | Class 2 | Electrodes with silver conductive | 2018 | 47 |
| Mouthpiece, Breathing | Class 1 | Mouth to mouth shield Mouthpiece CPR Mask KM-110 KM-101 KM-102 | 2017 | 67 |
| Perineometer | Class 2 | 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) | 2024 | 7 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | Class 2 | Stimulator, Electrical, NON-Implantable, FOR Incontinence, 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), Pelvic Muscle Trainer (KM510, KM516B), Biofeedback Nerve and Muscle Stimulator (Models: KM530B, KM531B, KM536, KM537), Stimulator | 2018 | 7 |
| Stimulator, Muscle, Powered | Class 2 | Stimulator | 2020 | 33 |
| Vibrator For Therapeutic Use, Genital | Class 2 | Pelvic Muscle Trainer | 2024 | 21 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Konmed | GXY | 12 |
| Konmed | KPI | 8 |
| Konmed /Pelvifine | KPI | 3 |
| Konmed | LQX | 3 |
| Konmed | BYP | 3 |
| Pelvic Muscle Trainer | KPI | 2 |
| Konmed /Pelvifine | IPF | 2 |
| Konmed | IQE | 1 |
| Konmed | ITW | 1 |
| Konmed /Pelvifine | HCC | 1 |
| Konmed /K-fit/pelvifine | KPI | 1 |
| Konmed | ILH | 1 |
| Konmed /Pelvifine | KXQ | 1 |
| Pelvifine | KXQ | 1 |
| Konmed | OHI | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260178 | 2026-06-18 | KPI | Traditional | This company |
| K233576 | 2024-02-23 | KPI | Traditional | This company |
| K220161 | 2022-07-20 | KPI | Traditional | This company |
| K202648 | 2020-12-08 | IPF | Traditional | This company |
| K163288 | 2018-01-18 | KPI | Traditional | This company |
| K171722 | 2018-01-10 | GXY | Traditional | This company |
| K171721 | 2018-01-05 | GXY | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Pelvic floor muscle training devices, TENS electrodes, CPR masks, Stimulators, Kegel toners |
|---|---|
| Certifications | EN ISO 13485, MDD Annex V, MDSAP 2016 |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.