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Data / Medical devices / United States / Eva Medtec, Inc

Eva Medtec, Inc: FDA-registered device maker in Shakopee, MN, United States, 1 510(k) clearance

Eva Medtec, Inc is registered with the FDA (registration 3018383120) in Shakopee, MN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 5, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3018383120
Address
1328 Ridge Court, Shakopee, MN, United States, 55379
Owner or operator
Eva Medtec, Inc (10081237)
Roles
Manufacturer
First device listed
March 28, 2021
Registered through
2026
Brand names listed
NeuroGlide

Devices it lists

DeviceProduct codeClassRoleSource
Massager, Powered Inflatable TubeIRP2Manufactureraccessdata.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 5, 2021K202693NeoWave Pain Relief and Recovery System, Model# T16-2020IRPSubstantially EquivalentEva Medtec, Inc.accessdata.fda.gov

Compare with other makers

Updated March 5, 2021. 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.