PREVENT I
Device Facts
| Record ID | K973373 |
|---|---|
| Device Name | PREVENT I |
| Applicant | The Buzzz Corp. |
| Product Code | INO · Physical Medicine |
| Decision Date | Feb 26, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3110 |
| Device Class | Class 2 |
Indications for Use
The intended use of this product is to make available a safety device for people using lift chairs to get from their feet to a seated position. This will ensure that the unit will stop if any thing is under the chair.
Device Story
Safety device for lift chairs; detects obstructions beneath chair during descent; stops chair movement upon detection; prevents potential injury or entrapment; intended for over-the-counter use by individuals utilizing lift chairs; provides automated safety intervention to ensure user safety during operation.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Safety sensor mechanism for lift chairs; designed to detect obstructions and interrupt power/motion; standalone safety component.
Indications for Use
Indicated for individuals using lift chairs who require a safety mechanism to prevent the chair from descending if an obstruction is detected beneath it.
Regulatory Classification
Identification
An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.
Special Controls
(1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure; (2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety; (3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device; (4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device; (5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety; (6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible; (7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented; (8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable; (9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and (10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.
