FDA Registration
Active
🇨🇳 China
SHENZHEN KONMED TECHNOLOGY CO., LTD
Reg #: 3011905669
·
FEI: 3011905669
·
Expires 2026
Products
8
Proprietary Names
9
Establishment Types
4
Classifications
8
Registration Details
- Registration Name
- SHENZHEN KONMED TECHNOLOGY CO., LTD
- Registration Number
- 3011905669
- FEI Number
- 3011905669
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 601, Building B4, Shenchengtou creative factory life science park, Julongshan A Road, Xiuxin block, Kengzi Street, Pingshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233576
Owner / Operator
- Firm Name
- Shenzhen Konmed Technology Co., Ltd
- Operator Number
- 10054707
- Address
- 601, Building B4, Shenchengtou creative factory life science park, Julongshan A Road, Xiuxin block, Kengzi Street, Pingshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518118
- Country
- CN
- Correspondent
- Shui Shan Yin
US Agent
- Business Name
- Performance International, Corp.
- Contact Name
- DENNIS XU DENNIS XU
- Address
- 2816 Sunset Ave
- City
- Rocky Mount
- State
- NC
- ZIP
- 27804
- Country
- US
- [email protected]
- Phone
- 919 8590478
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2018-01-23 |
| Perineometer | HIR | Class 2 | Obstetrics/Gynecology | No | 2024-02-29 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2024-02-29 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2017-06-02 |
| Vibrator For Therapeutic Use, Genital | KXQ | Class 2 | Obstetrics/Gynecology | No | 2024-12-30 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2020-12-08 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2020-12-08 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2026-03-23 |
Proprietary Names
Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013)
Incontinence Stimulation Electrode (Rectal Probe: KM-502, KM-5018)
Mouth to mouth shield Mouthpiece CPR Mask KM-110 KM-101 KM-102
Pelvic Muscle Trainer
STIMULATOR
Electrode Lead Wires
Biofeedback Nerve and Muscle Stimulator (Models: KM530B, KM531B, KM536, KM537)
STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
Electrodes with silver conductive
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198