Data / Medical devices / China / Shenzhen Gwode Technology Co., Ltd
Shenzhen Gwode Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Gwode Technology Co., Ltd is registered with the FDA (registration 3043709871) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 12, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043709871
- Address
- Room 522, Building 1, Bao'an Foreign Trade Industrial Zone, No. 51, Lane 1, Xin'an 3rd Road, Dalang Community Xin'an Street, Bao'an District, Shenzhen Guangdong, China, 518101
- Owner or operator
- Shenzhen Gwode Technology Co., Ltd (10095085)
- Roles
- Repackager or relabeler
- First device listed
- January 22, 2026
- Registered through
- 2026
- Brand names listed
- INCENTIVE SPIROMETER, Shock Wave Therapy Devices
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spirometer, Therapeutic (Incentive) | BWF | 2 | 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 |
|---|---|---|---|---|---|---|
| April 12, 2000 | K000314 | INCENTIVE SPIROMETER | BWF | Substantially Equivalent | Engineered Medical Systems | accessdata.fda.gov |
Compare with other makers
Updated April 12, 2000. 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.