FDA Registration
Active
🇨🇳 China
QK-Therapeutic Apparatus,model:QK-C01A,QK-C01B,QK-C01CZ,QK-C01EZ.QK-S14.QK-C02FZ,QK-C02D
Reg #: 3005280264
·
FEI: 3005280264
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD.
- Registration Number
- 3005280264
- FEI Number
- 3005280264
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 42-1 LANE 2, JING WEI STREET, DAOLI DISTRICT,
- City
- HARBIN Heilongjiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K141892
Owner / Operator
- Firm Name
- HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD.
- Operator Number
- 9038949
- Address
- 42-1 LANE 2, JING WEI STREET, DAOLI DISTRICT, HARBIN
- City
- HarBin
- State
- Heilongjiang
- Postal Code
- 150010
- Country
- CN
- Correspondent
- XIANGLIN WANG
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2015-03-23 |
Proprietary Names
QK-Therapeutic Apparatus,model:QK-C01A,QK-C01B,QK-C01CZ,QK-C01EZ.QK-S14.QK-C02FZ,QK-C02D
QK-Therapeutic Apparatus,model:QK-S05,QK-S07,QK-S08,QK-S09.QK-S10,QK-S15
QK-Therapeutic Apparatus model:QK-C02F,QK-S06
Establishment Types
Manufacture Medical Device