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Heelbo, Inc.

United StatesFDA applicant, unverified

Devices
14

What Heelbo, Inc. makes

Heelbo, Inc. manufactures patient safety and mobility aids, including protective garments like pull-over ponchos, sleeved jackets, and vests designed to prevent falls or injuries. Their product line also covers limb restraints, wrist restraints, and quilted limb holders with adjustable straps or buckles. Life jackets with crotch support and insulated mittens are part of their offerings, targeting clinical and emergency care environments.

All listed devices fall under Class I regulatory classification in the U.S. and are recorded in the FDA 510(k) database. The company operates from the United States, adhering to U.S. medical device regulations.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Frequently asked questions

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

The registry currently lists 14 devices for Heelbo, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Heelbo, Inc.'s devices?

Among its 14 most recently registered devices, Heelbo, Inc. has devices listed in FDA 510(k) (14 devices).

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

Among its 14 most recently registered devices, the classes recorded for Heelbo, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Heelbo, Inc. include HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET, HEELBO BLAZER SLEEVED JACKET, HEELBO WRAP AROUND VEST and THE L-BOW ARM RESTRAINT.

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