Data / Medical devices / China / Guangzhou Homesun Medical Technology Co., Ltd
Guangzhou Homesun Medical Technology Co., Ltd: FDA-registered device maker in Guangzhou Guangdong, China, 2 510(k) clearances
Guangzhou Homesun Medical Technology Co., Ltd is registered with the FDA (registration 3016218294) in Guangzhou Guangdong, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016218294
- Address
- Floor 7th,Tianxiang Business Building, No.28,Li Fu Road,Haizhu District, Guangzhou Guangdong, China, 510250
- Owner or operator
- Guangzhou Homesun Medical Technology Co., Ltd (10062023)
- Roles
- Manufacturer
- First device listed
- December 12, 2019
- Registered through
- 2026
- Brand names listed
- Breathing Mouthpiece (Model: Y1), Portable Diagnostic Spirometer, Model: PF-A9, Pulmonary Function Tester (Model :A9) SpiroLoop, Respiratory Muscle Trainer, Model: PF-T1, Smart Peak Flow Meter, Smart Respiratory Exerciser, SpiroLink, SpiroLink 2 Pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Predicted Values, Pulmonary Function | BTY | 2 | Manufacturer | accessdata.fda.gov |
| Exerciser, Measuring | ISD | 2 | Manufacturer | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | 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 |
|---|---|---|---|---|---|---|
| February 21, 2024 | K231561 | Pulmonary Function Tester, Model: A9 | BTY | Substantially Equivalent | Guangzhou Homesun Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 6, 2019 | K191239 | Smart Peak Flow Meter | BZH | Substantially Equivalent | Guangzhou Homesun Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthpiece, Breathing
- All makers of Exerciser, Measuring
- All makers of Meter, Peak Flow, Spirometry
- All makers of Calculator, Predicted Values, Pulmonary Function
Updated February 21, 2024. 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.