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Data / Medical devices / United States / Orthomed, LLC

Orthomed, LLC: FDA-registered device maker in Whittier, CA, United States, 1 510(k) clearance

Orthomed, LLC is registered with the FDA (registration 3009142693) in Whittier, CA, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 19, 2000. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3009142693
Address
9925 Painter Ave, Suite D, Whittier, CA, United States, 90605
Owner or operator
Orthomed, LLC (10036783)
Roles
Manufacturer, Repackager or relabeler
First device listed
May 25, 2011
Registered through
2026
Brand names listed
OrthoTHERM™ Smart Heating Pad, Tri-Wave, myHome Rehab Exercise Kit

Devices it lists

DeviceProduct codeClassRoleSource
Components, ExerciseIOD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, Water CirculatingILO2Repackager or relabeleraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Repackager 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
July 19, 2000K993420CONTROL SOLUTIONS INC, MODEL CS3101IPFSubstantially EquivalentControl Solutions, Inc.accessdata.fda.gov

Compare with other makers

Updated July 19, 2000. 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.