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Data / Medical devices / United States / Merchsource LLC

Merchsource LLC: FDA-registered device maker in Irvine, CA, United States, 3 510(k) clearances

Merchsource LLC is registered with the FDA (registration 3004126239) in Irvine, CA, United States. It lists 12 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 30, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Merchsource LLC
FDA registration number
3004126239
Address
7755 Irvine Center Drive Suite 100, Irvine, CA, United States, 92618
Owner or operator
Merchsource LLC (10041874)
Roles
Specification developer
First device listed
July 14, 2016
Registered through
2026
Brand names listed
Air Compression Boots, Cabinet, moist steam, DME Cane, DME Shower Chair, DME Walker Composite, Hot and Cold Eye Mask; Neck and Shoulder Wrap, Lamp,infrared,therapeutic heating, Light Therapy Decollete Mask and more

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, HygieneILS1Specification developeraccessdata.fda.gov
Cabinet, Moist SteamIMB2Specification developeraccessdata.fda.gov
CaneIPS1Specification developeraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Specification developeraccessdata.fda.gov
Light Based Over The Counter Wrinkle ReductionOHS2Specification developeraccessdata.fda.gov
Massager, Powered Inflatable TubeIRP2Specification developeraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Specification developeraccessdata.fda.gov
Massager, Therapeutic, ManualLYG1Specification developeraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Specification developeraccessdata.fda.gov
Pad, Heating, PoweredIRT2Specification developeraccessdata.fda.gov
Sunglasses (Non-Prescription Including Photosensitive)HQY1Specification developeraccessdata.fda.gov
Walker, MechanicalITJ1Specification developeraccessdata.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 30, 2025K251531AIR COMPRESSION BOOTS 1018195,1018196IRPSubstantially EquivalentMerchsource, LLCaccessdata.fda.gov
October 16, 2025K252093Light Therapy Mask (1019055)OHSSubstantially EquivalentMerchsource, LLCaccessdata.fda.gov
October 1, 2025K252096Light Therapy Decollete Mask (1019135)OHSSubstantially EquivalentMerchsource, LLCaccessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
August 1, 202290799Class IIOngoingThe product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.Excessive ultraviolet-C radiationaccessdata.fda.gov

Compare with other makers

Updated October 30, 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.