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Data / Medical devices / United States / Trumedx LLC

Trumedx LLC: FDA-registered device maker in Shelton, CT, United States, 5 510(k) clearances

Trumedx LLC is registered with the FDA (registration 3032062344) in Shelton, CT, United States. It lists 14 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 24, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Trumedx LLC
FDA registration number
3032062344
Address
1 Parrott Dr Ste 400, Shelton, CT, United States, 06484
Owner or operator
TrumedX LLC (10091324)
Roles
Complaint file establishment
First device listed
March 13, 2025
Registered through
2026
Brand names listed
Bighorn Ice, Bighorn Ice Plus, MOBIL-IZE Cryo Hip, MOBIL-IZE KNEE, MOBIL-IZE Shoulder, Slinger 90 TRU-X10790, Slinger TRU-X107, TruDVT and more

Devices it lists

DeviceProduct codeClassRoleSource
Joint, Hip, External BraceITS1Complaint file establishmentaccessdata.fda.gov
Joint, Knee, External BraceITQ1Complaint file establishmentaccessdata.fda.gov
Joint, Shoulder, External Limb ComponentIQQ1Complaint file establishmentaccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Complaint file establishmentaccessdata.fda.gov
Massager, Powered Inflatable TubeIRP2Complaint file establishmentaccessdata.fda.gov
Pack, Hot Or Cold, Water CirculatingILO2Complaint file establishmentaccessdata.fda.gov
Pad, Heating, PoweredIRT2Complaint file establishmentaccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Complaint file establishmentaccessdata.fda.gov
Sling, ArmILI1Complaint file establishmentaccessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For ArthritisNYN2Complaint file establishmentaccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Complaint file establishmentaccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Complaint file establishmentaccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Complaint file establishmentaccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Complaint file establishmentaccessdata.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
October 24, 2025K253150Cryon-X Cold CompressionIRPSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
May 1, 2024K240986Cold CompressionIRPSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
February 23, 2024K240011Lymphedema CompressionJOWSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
January 21, 2021K202839Overlapped Compression TherapyJOWSubstantially EquivalentJkh Health Co., Ltd.accessdata.fda.gov
June 21, 2019K191151JKH Stimulator PlusNUHSubstantially EquivalentJkh USA, LLCaccessdata.fda.gov

Compare with other makers

Updated October 24, 2025. 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.