(70 days)
These devices are Universal Gait Belt, Wheelchair Belt, Foam Limb Restraint, Double Buckle Limb Restraint, Comfort Safety Belt, Comfort Slider Belt, Universal Roll Belt and belt style restraints used to restrain patients in a wheelchair or bed. The devices are labeled for prescription use and are not intended for lay use.
These devices are made of polyester, cotton, nylon and polyethelen configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place.
This 510(k) summary (K96-3490) is for patient restraint devices, not a digital health device or AI-powered medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI performance metrics is not applicable to this submission.
The document describes physical patient restraint devices (Gait Belts, Wheelchair Belts, Limb Restraints, Safety Belts, Roll Belts). The summary states: "These devices have been commercially distributed for over for years and have not been associated with an MDR type complaint." This statement serves as the de facto "proof" that the device meets safety and effectiveness criteria for substantial equivalence, implying a history of safe use rather than a formal clinical study with performance metrics.
§ 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.