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Data / Medical devices / United States / Arboleaf Corporation

Arboleaf Corporation: FDA-registered device maker in Plano, TX, United States, 2 510(k) clearances

Arboleaf Corporation is registered with the FDA (registration 3017491419) in Plano, TX, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 26, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3017491419
Address
5465 Legacy Drive Suite 650, Plano, TX, United States, 75024
Owner or operator
Arboleaf Corporation (10078185)
Roles
Complaint file establishment, Repackager or relabeler
First device listed
March 25, 2021
Registered through
2026
Brand names listed
Arboleaf Body Composition Scale, Arboleaf Massage Gun, Arboleaf Massager, Arboleaf Scalp Massager, Arboleaf Upper Arm Blood Pressure Monitor SP10A, Arboleaf Upper Arm Blood Pressure Monitor SP20B, Arboleaf Upper Arm Blood Pressure Monitor U90B, Automatic Electronic Blood Pressure Monitor U90B

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Body Composition, ExemptPUH2Complaint file establishmentaccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Complaint file establishmentaccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Complaint file establishment, Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 26, 2026K260273Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)DXNSubstantially EquivalentShenzhen Urion Technology Co., Ltd.accessdata.fda.gov
June 29, 2023K230176Upper Arm Blood Pressure MonitorDXNSubstantially EquivalentShenzhen Yolanda Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated March 26, 2026. 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.