(34 days)
The Econo Belt is intended for the patient who requires a safety belt while seated in the wheelchair and who requires a reminder not to leave the wheelchair without assistance.
The Econo Belt is a two-inch-wide, six-foot-long wheelchair safety belt made from nylon webbing. Both ends have sewn loops which can be adjusted in size by means of metal slider buckles. The belt is positioned over the patient's waist, criss-crossed behind the wheelchair, and looped over the kickspurs. It is designed for wheelchair use only .
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document describes a medical device submission (510(k)) for a wheelchair safety belt, detailing its description, indications for use, and comparative information with a previously marketed device. However, it does not include any performance metrics, study designs, or acceptance criteria typical of medical device validation studies.
§ 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.