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The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho's are also intended to limit the patient's movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails.

The Heelbo Pullover Poncho and Pullover Poncho with Pocket are poncho-style safety vests. The Heelbo Pullover Poncho and Pullover Poncho with Pocket are intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Pullover Poncho's are also intended to limit the patient's movement while lying on a bed and to prevent the patient from falling out of bed or climbing over the side rails. The Heelbo Pullover Poncho has two straps that secure to the bed frame, wheelchair or geri-chair frame while the Pullover Poncho with Pocket has four straps that secure the bed frame, wheelchair or geri-chair frame. The Pullover Poncho with pocket provides the patient with a pocket to put personal items in. Both Heelbo Poncho restraints are available in a poly/cotton blend or a polyester mesh material and are available in five sizes to accommodate a wide range of patients. Both styles of pullover poncho are machine washable for continued use.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The text describes the device, its intended use, and states that it is substantially equivalent to predicate devices, but lacks the details requested in your prompt.

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