Guangzhou Homesun Medical Technology Co., Ltd.
Registered establishment in Guangzhou, Guangdong, China. 4 device types, 2 clearances.
Guangzhou Homesun Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Exerciser, Measuring, Mouthpiece, Breathing and 2 other device types. Its earliest product listing with the FDA dates from 2019.
4device types registered with the FDA
2510(k) clearances
Registration
| Registered name | GUANGZHOU HOMESUN MEDICAL TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016218294 |
| FEI number | 3016218294 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 广州红象医疗科技有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | Floor 7th,Tianxiang Business Building, No.28,Li Fu Road,Haizhu District |
| Postal code | 510250 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Calculator, Predicted Values, Pulmonary Function | Class 2 | SpiroLink 2 Pro, Portable Diagnostic Spirometer, Model: PF-A9, SpiroMeter,Model B300, Pulmonary Function Tester (Model :A9) SpiroLoop | 2024 | 1 |
| Exerciser, Measuring | Class 2 | Respiratory Muscle Trainer, Model: PF-T1, Smart Respiratory Exerciser, T1, TA | 2021 | 14 |
| Meter, Peak Flow, Spirometry | Class 2 | Smart Peak Flow Meter, SpiroLink | 2019 | 6 |
| Mouthpiece, Breathing | Class 1 | Breathing Mouthpiece (Model: Y1) | 2019 | 67 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K231561 | 2024-02-21 | BTY | Traditional | This company |
| K191239 | 2019-12-06 | BZH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Main products | Pulmonary function testing, Infant respiratory measurement, Respiratory muscle strength devices, Cardiopulmonary exercise testing, Respiratory rehabilitation |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.