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Data / Medical devices / Canada / Headstart Medical

Headstart Medical: FDA-registered device maker in New Westminster British Columbia, Canada, 1 510(k) clearance

Headstart Medical is registered with the FDA (registration 3045077481) in New Westminster British Columbia, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 7, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3045077481
Address
5th Avenue, New Westminster British Columbia, Canada, V3M1X4
Owner or operator
HeadStart Medical (10095464)
Roles
Manufacturer
First device listed
March 16, 2026
Registered through
2026
Brand names listed
SnugKap

Devices it lists

DeviceProduct codeClassRoleSource
Orthosis, CranialMVA2Manufactureraccessdata.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
June 7, 2021K193383SnugKapMVASubstantially EquivalentHeadstart, Ltd.accessdata.fda.gov

Compare with other makers

Updated June 7, 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.