Data / Medical devices / China / Ningbo Kk-Bioscience Co., Ltd.
Ningbo Kk-Bioscience Co., Ltd.: FDA-registered device maker in Ningbo Zhejiang, China, 2 510(k) clearances
Ningbo Kk-Bioscience Co., Ltd. is registered with the FDA (registration 3018269548) in Ningbo Zhejiang, China. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 10, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3018269548
- Address
- No.38, Dongzhou Industrial Park, Xi`dian, Ninghai, Ningbo Zhejiang, China, 315613
- Owner or operator
- Ningbo KK-Bioscience Co., Ltd. (10080171)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- January 16, 2021
- Registered through
- 2026
- Brand names listed
- Auto chill cold therapy device, Cold Therapy Device, Cold and Compression Therapy, Compression Garments, Deep vein thrombosis (DVT) sleeve, Portable DVT System, Pressure Infusion Bag, Stethoscope and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Exporter to the US, 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 10, 2022 | K213097 | Armory Motion | ILO | Substantially Equivalent | Pain Management Technologies, Inc. | accessdata.fda.gov |
| November 18, 2021 | K211937 | SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System | JOW | Substantially Equivalent | Jiangsu Synecoun Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Sleeve, Limb, Compressible
- All makers of Stethoscope, Manual
- All makers of Pack, Hot Or Cold, Reusable
- All makers of Infusor, Pressure, For I.V. Bags
- All makers of Pack, Hot Or Cold, Water Circulating
- All makers of Orthosis, Limb Brace
Updated June 10, 2022. 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.