Data / Medical devices / China / Changchun Aik Medical Devices Co., Ltd.
Changchun Aik Medical Devices Co., Ltd.: FDA-registered device maker in Changchun Jilin, China, 1 510(k) clearance
Changchun Aik Medical Devices Co., Ltd. is registered with the FDA (registration 3013950830) in Changchun Jilin, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 11, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013950830
- Address
- No. 1188, jia 'er road, jiutai economic development zone, Changchun, Changchun Jilin, China, 130507
- Owner or operator
- CHANGCHUN AIK MEDICAL DEVICES CO., LTD. (10055721)
- Roles
- Manufacturer
- First device listed
- September 23, 2017
- Registered through
- 2026
- Brand names listed
- Aik, KMA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Acupuncture, Single Use | MQX | 2 | 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 |
|---|---|---|---|---|---|---|
| May 11, 2017 | K162566 | AIK Sterile Acupuncture Needles for Single Use | MQX | Substantially Equivalent | Changchun Aik Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 11, 2017. 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.