Data / Medical devices / China / Xiamen Compower Medical Tech. Co., Ltd.
Xiamen Compower Medical Tech. Co., Ltd.: FDA-registered device maker in Xiamen Fujian, China, 6 510(k) clearances
Xiamen Compower Medical Tech. Co., Ltd. is registered with the FDA (registration 3008261717) in Xiamen Fujian, China. It lists 9 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 16, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3008261717
- Address
- Unit 301 No. 16 Xianghong Road, Xiamen Fujian, China, 361115
- Owner or operator
- Xiamen Compower Medical Tech. Co., Ltd. (10031696)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- March 1, 2010
- Registered through
- 2027
- Brand names listed
- Anesthesia mask, CPR Mask with Oxygen Port, CPR Mask without Oxygen Port, Cardiopulmonary Resuscitation Aid Kit, with CPR Mask, Collar,Adjustable Collars, Fixed Collars, Disposable Manual Resuscitator, Disposable Manual Resuscitator, PVC Manual Resuscitator, Disposable Manual Resuscitator, PVC manual resuscitator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Manufacturer | accessdata.fda.gov |
| Cardiopulmonary Resuscitation Aid Kit | OEV | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Valve, Non-Rebreathing | CBP | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | 2 | Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 16, 2026 | K263254 | Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) | BTM | Substantially Equivalent | Xiamen Compower Medical Tech. Co., Ltd. | accessdata.fda.gov |
| August 26, 2021 | K210288 | Disposable Manual Resuscitator | BTM | Substantially Equivalent | Xiamen Compower Medical Tech. Co., Ltd. | accessdata.fda.gov |
| July 12, 2021 | K210723 | Nitrile Patient Examination Glove | LZA | Substantially Equivalent | Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
| October 6, 2018 | K182117 | Vinyl Patient Examination Gloves | LYZ | Substantially Equivalent | Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
| November 17, 2017 | K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) | CBP | Substantially Equivalent | Xiamen Compower Medical Tech. Co., Ltd. | accessdata.fda.gov |
| March 9, 2016 | K152712 | Nitrile Powder Free Patient Examination Gloves, Blue Color | LZA | Substantially Equivalent | Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Ventilator, Emergency, Manual (Resuscitator)
- All makers of Cardiopulmonary Resuscitation Aid Kit
- All makers of Valve, Non-Rebreathing
- All makers of Polymer Patient Examination Glove
- All makers of Mask, Gas, Anesthetic
Updated October 16, 2026. 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.