Data / Medical devices / China / Shenzhen Ruiyi Business Technology Co., Ltd.
Shenzhen Ruiyi Business Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 14 510(k) clearances
Shenzhen Ruiyi Business Technology Co., Ltd. is registered with the FDA (registration 3021282523) in Shenzhen Guangdong, China. It lists 13 device types. The FDA files 14 510(k) clearances under its listings, the newest dated February 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021282523
- Address
- No. 810-C063, 8th Floor, Xiangbin International Financial Centre, No.18, West Free Trade Street, China Special Economic Zone, Qianhai Bay, Shenzhen, Guangdong Province, 518000 China, Shenzhen Guangdong, China, 518000
- Owner or operator
- Shenzhen Ruiyi Business Technology Co., Ltd. (10083379)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- December 2, 2021
- Registered through
- 2026
- Brand names listed
- 2 in 1 Foot and Calf Massager:R-D002RS, Abdominal Massager:I-B-101, Air Compression Leg Massager: YY-A01L, Air Compression Therapy Device: ST-502, Air compression Leg Massager : MM0521, MM0522, Blood Pressure Monitor: TMB-2276-B, Body Composition Scale: F-MSC03,F-MSC02, R-MSC03, R-MSC04, R-MSC05,R-MSC06,R-MSC07,R-MSC08, Body Composition Scale: FT-24D,R-A003,ES-26R-B, R-A019,FA-01, FA-03, R-MSC02 ,R-MSC01,R-A009 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Cold Pack And Vibrating Massager | PHW | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Exporter to the US, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 19, 2025 | K241578 | Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | DXN | Substantially Equivalent | Shenzhen Bsx Technology Electronics Co., Ltd. | accessdata.fda.gov |
| February 5, 2025 | K243555 | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) | OLP | Substantially Equivalent | Shenzhen Eyco Technology Co., Ltd. | accessdata.fda.gov |
| November 20, 2024 | K232965 | Leg Massager (Models:RP-ALM070H, RP-ALM071H) | IRP | Substantially Equivalent | Shenzhen Ruiyi Business Technology Co., Ltd. | accessdata.fda.gov |
| September 17, 2024 | K240373 | Air compression Leg Massager (MM0520, MM0521, MM0522) | IRP | Substantially Equivalent | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | accessdata.fda.gov |
| August 2, 2024 | K240981 | Air compression leg massager | IRP | Substantially Equivalent | Huizhou Xinyi Technology Co., Ltd. | accessdata.fda.gov |
| April 29, 2024 | K240102 | Blood Pressure Monitor (TMB-2287-B) | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| November 28, 2023 | K232713 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| March 28, 2023 | K223928 | Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K | OHT | Substantially Equivalent | Shenzhen Fansizhe Science and Technology Co., Ltd. | accessdata.fda.gov |
| March 15, 2023 | K222991 | Air Compression Leg Massager (model: EMK-701) | IRP | Substantially Equivalent | Xiamen Emoka Health Science & Technology Co., Ltd. | accessdata.fda.gov |
| December 23, 2022 | K222924 | Leg Massager RF-ALM070 | IRP | Substantially Equivalent | Shenzhen Ruiyi Business Technology Co., Ltd. | accessdata.fda.gov |
| December 8, 2022 | K221862 | YY-A02-B Overlapped Compression Therapy | IRP | Substantially Equivalent | Huizhou Xinyi Technology Co., Ltd. | accessdata.fda.gov |
| March 31, 2022 | K213745 | Air Compression Therapy Device, model: ST-502 | IRP | Substantially Equivalent | Shenzhen Future Electronic Co., Ltd. | accessdata.fda.gov |
| June 19, 2013 | K131395 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| January 31, 2012 | K120058 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pad, Heating, Powered
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Massager, Powered Inflatable Tube
- All makers of Heat Source For Bleaching Teeth
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
Updated February 19, 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.