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Framesmart, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
2

What Framesmart, Inc. makes

Framesmart, Inc. manufactures orthopedic devices for spinal and extremity support, including the FITO DIDO and MARCELLA CARAN, which are designed for post-surgical stabilization and mobility assistance.

These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Fito Dido Ref K963075

    Class I
    Active 510(k) 510(k) I

  • Marcella Caran Ref K962912

    Class I
    Active 510(k) 510(k) I

Frequently asked questions

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

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

Which registries list Framesmart, Inc.'s devices?

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

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

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

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

The most recently registered devices listed for Framesmart, Inc. include FITO DIDO and MARCELLA CARAN.

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