Data / Medical devices / United States / FKA Distributing Co., LLC

FKA Distributing Co., LLC: FDA-registered device maker in Commerce Township, MI, United States, 25 510(k) clearances

FKA Distributing Co., LLC is registered with the FDA (registration 1832894) in Commerce Township, MI, United States. It lists 20 device types. The FDA files 25 510(k) clearances under its listings, the newest dated December 22, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number

1832894

Address

3000 N Pontiac Trl, Commerce Township, MI, United States, 48390

Owner or operator

FKA Brands (1832894)

Roles

Complaint file establishment, Repackager or relabeler

First device listed

March 8, 2004

Registered through

2026

Brand names listed

7LS, HoMedics, HoMedics Bubble Bliss Elite Footbath, Homedics, ObusForme

Devices it lists

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.

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

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Updated December 22, 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.