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Data / Medical devices / United States / Wearlinq

Wearlinq: FDA-registered device maker in Rockville, MD, United States, 1 510(k) clearance

Wearlinq is registered with the FDA (registration 3021332567) in Rockville, MD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 20, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3021332567
Address
1803 Research Blvd #600, Rockville, MD, United States, 20850
Owner or operator
WearLinq (10087780)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
April 7, 2023
Registered through
2026
Brand names listed
eWave

Devices it lists

DeviceProduct codeClassRoleSource
Recorder, Magnetic Tape, MedicalDSH2Complaint file establishment, Manufacturer, Specification developeraccessdata.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
October 20, 2022K214073eWave MonitorDSHSubstantially EquivalentWearlinq, Inc.accessdata.fda.gov

Compare with other makers

Updated October 20, 2022. 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.