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Advanced Cooling Therapy, Inc. D/B/A Attune Medical

United StatesFDA applicant, unverified

Devices
3

What Advanced Cooling Therapy, Inc. D/B/A Attune Medical makes

Advanced Cooling Therapy, Inc. manufactures the Enso™, a device designed for targeted tissue cooling to reduce inflammation and pain, primarily used in post-surgical and acute injury management.

The Enso™ is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.

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

Catalogue3

Newest first, rows 1-3 of 3

  • EnsoETM Ref K180742

    Active Regimes: CE MDD 510(k) Registry: 510(k) Class:II

  • EnsoETM Ref K180244

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • ensoETM Ref DEN230021

    Active Regimes: CE MDD De Novo Registry: De Novo Class:II

Frequently asked questions

How many devices does Advanced Cooling Therapy, Inc. D/B/A Attune Medical have in the registry?

The registry currently lists 3 devices for Advanced Cooling Therapy, Inc. D/B/A Attune Medical. Devices recorded under merged duplicate company entries are counted once.

Which registries list Advanced Cooling Therapy, Inc. D/B/A Attune Medical's devices?

Among its 3 most recently registered devices, Advanced Cooling Therapy, Inc. D/B/A Attune Medical has devices listed in FDA 510(k) (3 devices).

What risk classes do Advanced Cooling Therapy, Inc. D/B/A Attune Medical's devices fall under?

Among its 3 most recently registered devices, the classes recorded for Advanced Cooling Therapy, Inc. D/B/A Attune Medical's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Advanced Cooling Therapy, Inc. D/B/A Attune Medical in the registry?

The most recently registered devices listed for Advanced Cooling Therapy, Inc. D/B/A Attune Medical include EnsoETM.

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