Ningbo KK-Bioscience Co., Ltd.
Registered establishment in Ningbo, Zhejiang, China. 6 device types.
Ningbo KK-Bioscience Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Stethoscope, Manual, Orthosis, Limb Brace and 4 other device types. Its earliest product listing with the FDA dates from 2021.
Registration
| Registered name | NINGBO KK-BIOSCIENCE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3018269548 |
| FEI number | 3018269548 |
| Establishment type | Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 宁波康慷生物科技有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Ningbo |
|---|---|
| Province | Zhejiang |
| Address | No.38, Dongzhou Industrial Park, Xi`dian, Ninghai |
| Postal code | 315613 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Infusor, Pressure, For I.V. Bags | Class 1 | Pressure Infusion Bag | 2021 | 25 |
| Orthosis, Limb Brace | Class 1 | Deep vein thrombosis (DVT) sleeve, Compression Garments, massage sleeve | 2023 | 144 |
| Pack, Hot Or Cold, Reusable | Class 1 | Auto chill cold therapy device | 2022 | 178 |
| Pack, Hot Or Cold, Water Circulating | Class 2 | Cold Therapy Device, Cold and Compression Therapy | 2021 | 45 |
| Sleeve, Limb, Compressible | Class 2 | Portable DVT System | 2026 | 24 |
| Stethoscope, Manual | Class 1 | Stethoscope | 2021 | 64 |
Clearances
No clearance names Ningbo KK-Bioscience Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K213097 | 2022-06-10 | ILO | Traditional | Pain Management Technologies |
| K211937 | 2021-11-18 | JOW | Traditional | Jiangsu Synecoun Medical Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1997 |
|---|---|
| Main products | Cold therapy machines, Pressure infusion bags, DVT sleeves, Blood pressure accessories, Tourniquets |
| Export markets | 50+ countries |
| OEM and ODM | Offered |
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.