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Data / Medical devices / United States / Marketwinch Inc.

Marketwinch Inc.: FDA-registered device maker in Jericho, NY, United States, 2 510(k) clearances

Marketwinch Inc. is registered with the FDA (registration 3035781155) in Jericho, NY, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 23, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3035781155
Address
35 17th St, Jericho, NY, United States, 11753
Owner or operator
Marketwinch Inc. (10092691)
Roles
Repackager or relabeler
First device listed
August 28, 2025
Registered through
2027
Brand names listed
MyoSleeve

Devices it lists

DeviceProduct codeClassRoleSource
Massager, Powered Inflatable TubeIRP2Repackager or relabeleraccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Repackager 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
December 23, 2024K243177SACS PROIRPSubstantially EquivalentElastimed , Ltd.accessdata.fda.gov
December 22, 2023K232300ElastiMed SACSJOWSubstantially EquivalentElastimed , Ltd.accessdata.fda.gov

Compare with other makers

Updated December 23, 2024. 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.