(88 days)
Heelbo Ouilted Limb Holder with Double D-Ring. Ouick-Release Snap, and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions.
Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is a disposable quilted limb holder with a Velcro® fastener, Double D-Ring, Quick-Release Snap and Straps that secure to a bed, gurney, chair or wheelchair. The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The Heelbo Quilted Limb Holder allows for wrist adjustment to provide a secure fit without cinching. The Double D-Ring is simple to use and allows the caregiver easy access to the patient. Also, the adjustable Double D-Ring and Quick-Release Snap allow for supine and sitting positions. The Heelbo Quilted Limb Holders are machine washable.
The Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap and Strap is available in the following sizes:
Stock No. 9350 Small-Regular / cuff size: 11 1/2" long strap: 3/4" wide, 60" long
Stock No. 9360 Large-X-Large / cuff size: 13 1/2" long strap: 3/4" wide, 60" long
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification summary for a medical device (Heelbo Quilted Limb Holder), focusing on its intended use, description, and substantial equivalence to a predicate device. It addresses aspects like technological characteristics and biocompatibility based on material history of safe use, but it does not detail specific performance metrics, clinical studies, or expert evaluations as requested in the prompt.
Therefore, I cannot extract the information needed to fill out the table and answer the questions about acceptance criteria and a detailed study.
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.