Data / Medical devices / China / Shenzhen Yolanda Technology Co., Ltd.
Shenzhen Yolanda Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Yolanda Technology Co., Ltd. is registered with the FDA (registration 3014630021) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014630021
- Address
- Room 201, Jinfulai Building, No.49-1, Dabao Road, Dalang Area, Xinan Street, Baoan, Shenzhen, China Room, 1-5 Floor, Building2, No. 8, Dongsheng Road, JiangHai District, JiangMen, Guangdong, China, Shenzhen Guangdong, China, 518000
- Owner or operator
- Shenzhen Yolanda Technology Co., Ltd. (10057904)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 11, 2018
- Registered through
- 2026
- Brand names listed
- Body Composition Scale, model of CS10K,CS10P,CS10G,CS10H,CS10E,CS10J, Body Composition Scale, model of CS20C,CS20A, CS20M,CS20N,CS20L,CS20G,CS20W,CS20F,CS20R,CS20P,Fit Plus LN,CS20T,Fit Plus, Body Composition Scale, model of ES-CS20M,ES-CS20M-W,ES-32MD,ES-26M,R-A019,R-A005,ES-30M,ES-28ML, Body Composition Scale/Body Composition Analyzer,model of SCL-BBC250-BK,SCL-BBC250-WT,SCL-BBC350-BK,SCL-BBC350-WT, Body Composition Scale/Body Composition Analyzer,model of SCL-XBC200-BK, SCL-XBC200-WT, SCL-BBC200-BK,SCL-BBC200-WT, Compact Percussion Massager, model of 239857, Massager gun, model of CM20C,CM20F,CM40G, Scale and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 |
|---|---|---|---|---|---|---|
| June 29, 2023 | K230176 | Upper Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Yolanda Technology Co., Ltd. | accessdata.fda.gov |
| August 26, 2022 | K221212 | Upper Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Yolanda Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Scale, Patient
- All makers of Massager, Therapeutic, Electric
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Analyzer, Body Composition, Exempt
Updated June 29, 2023. 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.