Data / Medical devices / China / Wenzhou Kangju Medical Instrument Co., Ltd.
Wenzhou Kangju Medical Instrument Co., Ltd.: FDA-registered device maker in Wenzhou Zhejiang, China, 2 510(k) clearances
Wenzhou Kangju Medical Instrument Co., Ltd. is registered with the FDA (registration 3016170451) in Wenzhou Zhejiang, China. It lists 15 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 28, 2022. Registered through 2027. 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
- 3016170451
- Address
- 81 Liuzhai Luodong South Street Yongzhong, Wenzhou Zhejiang, China, 325000
- Owner or operator
- Wenzhou Kangju Medical Instrument Co. Ltd (10039342)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 29, 2011
- Registered through
- 2027
- Brand names listed
- Adaptor, Hygiene, Aneroid Sphygmomanometer, Blood Pressure Monitor, Bottle hot/cold water, Cane, Cushion Pad, Foot Spa Massager, Foot Massager, Neck and Shoulder Massager, Massage Cushion, Massage Hammer, Massage Pillow; Massage G, Fork, Heating Pad and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Hygiene | ILS | 1 | Exporter to the US | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bottle, Hot/Cold Water | FPF | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cane | IPS | 1 | Exporter to the US | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Fork, Tuning | GWX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Exporter to the US | accessdata.fda.gov |
| Percussor | GWZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pinwheel | GWY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Exporter to the US | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| November 28, 2022 | K222652 | Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer | DXQ | Substantially Equivalent | Cardicare Company, Ltd. | accessdata.fda.gov |
| September 24, 2012 | K122259 | BLOOD PRESSURE MONITOR WITH STETHOSCOPE | DXQ | Substantially Equivalent | Hangzhou Reli-On Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cane
- All makers of Adaptor, Hygiene
- All makers of Scissors, General, Surgical
- All makers of Light, Examination, Medical, Battery Powered
- All makers of Blood Pressure Cuff
- All makers of Bottle, Hot/Cold Water
Updated November 28, 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.