(68 days)
The Zimmer line of restraints is intended for restless, confused, elderly, or unsteady patients. They help prevent such patients from injuring themselves or clinical personnel. The most common emergency indications for patient restraints are: emotional/psychological disturbance, threatened or attempted suicide, suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints may also be indicated for post-op patients in recovery, patients under sedation, and patients suffering from stroke, neuromuscular disorders, or Alzheimer's disease. Zimmer restraints are not intended for patients who may be exceptionally violent. Such patients may require devices made from heavier materials and specifically designed for patients with serious mental disturbances.
Limb Holders (protective restraints) Foam Limb Holder w/Quick Release Buckle Proprietary Names: Polvester Pile Wrist/Ankle Restraint Soft Flannel Wrist/Ankle Restraint Wrist Restraint, Universal
The provided text is a 510(k) summary for Zimmer Limb Holders (protective restraints) from 1996. It details the device's intended use, classification, and comparison to existing legally marketed devices. However, it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria.
The document discusses:
- Safety and Effectiveness: It states that the Zimmer line of restraints has been manufactured and in commercial distribution for over 20 years and are exempt from 510(k) premarket notification procedures and Good Manufacturing Practice Regulations.
- Intended Use: To prevent restless, confused, elderly, or unsteady patients from injuring themselves or clinical personnel.
- Regulatory Context: It mentions Health Care Financing Administration Regulations and Joint Commission on Accreditation of Healthcare Organizations standards related to restraint use, emphasizing appropriate supervision and least restrictive restraint.
- Problems: States that the most significant problems with restraints are attributed to misuse or misapplication, not design or materials.
Therefore, I cannot provide the requested information as it is not present in the given text. The document focuses on regulatory classification and existing market presence rather than a detailed performance study with specific acceptance criteria.
§ 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.