Data / Medical devices / China / Xemis Medical Technology (shenzhen) Co., Ltd.
Xemis Medical Technology (shenzhen) Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Xemis Medical Technology (shenzhen) Co., Ltd. is registered with the FDA (registration 3038197172) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 7, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3038197172
- Address
- 5th Floor, Building 369, Baotian 1st Road, Tiegang Community, Xixiang Street, Baoan, Shenzhen Guangdong, China, 518102
- Owner or operator
- Xemis Medical Technology (Shenzhen) Co., Ltd. (10093075)
- Roles
- Manufacturer
- First device listed
- March 27, 2025
- Registered through
- 2026
- Brand names listed
- Photon Therapy Apparatus (model: BL-10), Ultrasound Therapy Workstation
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interferential Current Therapy | LIH | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Neuromuscular, External Functional | GZI | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | IMG | 2 | 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 |
|---|---|---|---|---|---|---|
| October 7, 2025 | K244041 | Ultrasound Therapy Workstation (XMS-UET2) | IMG | Substantially Equivalent | Xemis Medical Technology (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| March 13, 2025 | K243993 | Photon Therapy Apparatus (BL-10) | GEX | Substantially Equivalent | Xemis Medical Technology (Shenzhen) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Interferential Current Therapy
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Neuromuscular, External Functional
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- All makers of Powered Laser Surgical Instrument
Updated October 7, 2025. 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.