(34 days)
The Double Support Poncho is used for restraint and to provide upper body posture support.
The Slider Poncho provides restraint, posture support, and slider control.
Double Support Poncho: A poncho-style, upper body device made from either woven polyester or polyester mesh. A chest strap is used to provide upper body posture support. A waist strap secures the device the device to wheelchair kickspurs. All straps are 1 1/8-inch-wide polyester webbing. The edges of the garment are finished with a bias cut binding, the color of which corresponds to a size chart included on the package insert. Device is intended for wheelchair use only.
Slider Poncho: The Slider Poncho has the same configuration as the above with the addition of a crotch pad sewn to the bottom center front. The pad is lined with 1/4 inch polyurethane foam and has a 1 and 1 1/8 inch strap sewn on that is either placed directly under the patient or under the wheelchair seat and secured to the wheelchair cross brace to prevent the patient from sliding down.
This appears to be a 510(k) summary for a medical device (Double Support Poncho and Slider Poncho) that was submitted in 1996. The document describes the device, its intended use, and its predicate devices.
However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It focuses on the device description, indications for use, and a comparison to already marketed, legally exempt devices. It also briefly mentions regulatory aspects concerning patient restraints in nursing homes.
Therefore, I cannot provide the requested table and detailed information as the source document does not contain the necessary data about performance metrics or a study demonstrating those metrics.
To answer your request, I would need a document that describes:
- Specific performance metrics the device is expected to meet (e.g., "device prevents user from sliding down 95% of the time").
- A study protocol or results that detail how these metrics were tested and what the outcomes were.
§ 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.