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Data / Medical devices / France / Sublimed

Sublimed: FDA-registered device maker in Moirans Auvergne-Rhone-Alpes, France, 2 510(k) clearances

Sublimed is registered with the FDA (registration 3015588280) in Moirans Auvergne-Rhone-Alpes, France. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 16, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3015588280
Address
137 Rue Mayoussard, Moirans Auvergne-Rhone-Alpes, France, 38380
Owner or operator
SUBLIMED (10088953)
Roles
Complaint file establishment, Manufacturer, Specification developer
First device listed
October 24, 2023
Registered through
2026
Brand names listed
Charging Case spare, actiTENS Android app, actiTENS Standard Kit, actiTENS iOs app, actiTENS mini KIT, actiTENS mini Textile Accessory, actiTENS mini spare, actiTENS spare and more

Devices it lists

DeviceProduct codeClassRoleSource
Stimulator, Electrical, Transcutaneous, For ArthritisNYN2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Stimulator, Muscle, PoweredIPF2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle ConditioningNGX2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-CounterNUH2Complaint file establishment, Manufacturer, Specification 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
January 16, 2026K252767actiTENS miniGZJSubstantially EquivalentSublimedaccessdata.fda.gov
December 22, 2020K202159actiTENSGZJSubstantially EquivalentSublimedaccessdata.fda.gov

Compare with other makers

Updated January 16, 2026. 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.