TWO RIVERS POWER LIFT/RECLINE CHAIR
Device Facts
| Record ID | K991693 |
|---|---|
| Device Name | TWO RIVERS POWER LIFT/RECLINE CHAIR |
| Applicant | Two Rivers, LLC |
| Product Code | INO · Physical Medicine |
| Decision Date | Aug 17, 1999 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3110 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
To be used by the aged or partially disabled individuals to help them rise to a standing position from a seated position.
Device Story
Two Rivers Power Lift/Recline Chair is a motorized furniture device designed to assist aged or partially disabled individuals in transitioning from a seated to a standing position. The device operates via an integrated electric motor mechanism controlled by the user to lift and recline the chair frame. It is intended for use in home or clinical settings by the patient. The device provides mechanical assistance to reduce the physical effort required for standing, thereby promoting patient independence and mobility.
Clinical Evidence
Bench testing only.
Technological Characteristics
Motorized lift and recline mechanism; electric power source; furniture-based form factor.
Indications for Use
Indicated for aged or partially disabled individuals requiring assistance transitioning from a seated to a standing position.
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.
