Data / Medical devices / China / Jiangmen Dacheng Medical Equipment Co., Ltd.
Jiangmen Dacheng Medical Equipment Co., Ltd.: FDA-registered device maker in Jiangmen Guangdong, China, 3 510(k) clearances
Jiangmen Dacheng Medical Equipment Co., Ltd. is registered with the FDA (registration 3010168054) in Jiangmen Guangdong, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated December 27, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010168054
- Address
- #8 South of Jiaobei Hengkeng Jianghai District, Jiangmen Guangdong, China, 529000
- Owner or operator
- Gentherm Medical LLC (10042384)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 27, 2017
- Registered through
- 2026
- Brand names listed
- Extra Large Size Warming Suit IOB-304, IOB Temperature Management System Model IOB-507, IOB Warming Blanket, IOB Warming Blankets, IOB-001/IOB-001S Torso Warming Blanket, IOB-002/IOB-002S Lower Body Warming Blanket, IOB-003/IOB-003S Upper Body Warming Blanket, IOB-004/IOB-004S Full Body Warming Blanket and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Thermal Regulating | DWJ | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| December 27, 2022 | K221669 | IOB Warming Blankets | DWJ | Substantially Equivalent | Iob Medical, Inc. | accessdata.fda.gov |
| October 25, 2019 | K190221 | IOB Warming Blankets | DWJ | Substantially Equivalent | Iob Medical, Inc. | accessdata.fda.gov |
| April 28, 2017 | K162679 | IOB Temperature Management System | DWJ | Substantially Equivalent | Iob Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 27, 2022. 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.