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Trileen, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
2

What Trileen, Inc. makes

Trileen, Inc. manufactures the MASSATOR-PEDIO, a device designed for pediatric foot massaging, and the BIOTHERM, a thermal therapy unit for localized heating applications.

The company’s portfolio includes Class I and Class II devices, with products listed under the FDA’s 510(k) clearance pathway. Trileen, Inc. is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Massator-Pedio Ref K833840

    Class I
    Active 510(k) 510(k) I
  • Biotherm Ref K833839

    Class II
    Active 510(k) 510(k) II

Frequently asked questions

How many devices does Trileen, Inc. have in the registry?

The registry currently lists 2 devices for Trileen, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Trileen, Inc.'s devices?

Among its 2 most recently registered devices, Trileen, Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Trileen, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Trileen, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Trileen, Inc. in the registry?

The most recently registered devices listed for Trileen, Inc. include MASSATOR-PEDIO and BIOTHERM.

Generated automatically from registry data and not verified by a human reviewer.