Data / Medical devices / China / Shenzhen Raycome Health Technology Co., Ltd
Shenzhen Raycome Health Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Raycome Health Technology Co., Ltd is registered with the FDA (registration 3009690509) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 15, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009690509
- Address
- No.201,Blk 8,Piovan Creative Fty,No.1051,Songbai Rd,Yangguang Community,Xili Street,Nanshan District,Shenzhen., Shenzhen Guangdong, China, 518055
- Owner or operator
- Shenzhen Raycome Health Technology CO., LTD (10057042)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- February 13, 2018
- Registered through
- 2026
- Brand names listed
- BP-BT Kiosk, Knee care Massager
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | 2 | Exporter to the US | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| May 15, 2020 | K200287 | BP-BT Kiosk | DXN | Substantially Equivalent | Ld Technology, LLC | accessdata.fda.gov |
| December 19, 2017 | K173696 | TBL-ABI System | JOM | Substantially Equivalent | Ld Technology, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Updated May 15, 2020. 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.