STANDARD WHEELCHAIR PLATFORM
Device Facts
| Record ID | K073565 |
|---|---|
| Device Name | STANDARD WHEELCHAIR PLATFORM |
| Applicant | Design Specific , Ltd. |
| Product Code | INO · Physical Medicine |
| Decision Date | Feb 6, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3110 |
| Device Class | Class 2 |
Indications for Use
Patients in wheelchairs present problems to clinicians who need to treat them and the patients themselves can be seriously disadvantaged by their situation. This is particularly true of dental treatment. To be treated the dentist would need to bend around the patient in the wheelchair, that cusses back pain and sometimes injury. An alternate approach is to transfer the patient to a conventional chair by slings and hoists or other approaches, all of which hold significant health and safety risks. The wheelchair platform offers a safe environment for both clinician and patient. The wheelchair is moved onto the platform up against a back wall support and the wheelchair and patient are then supported by a backrest and a head support. The platform is reclined, and possibly raised and lowered, to present the patient in the best position for treatment.
Device Story
Standard Wheelchair Platform provides secure support for patients remaining in wheelchairs during medical/dental procedures. Device consists of steel platform with adjustable backrest and head cushion; wheelchair is rolled onto platform and secured against back wall. Electrical linear drive tilts platform up to 45 degrees to optimize patient positioning for clinician access. Operated by clinician via fixed switches or radio remote control. Includes pressure-sensitive mat and guarding for foot crush protection. Mobility provided by air cushion pads or ball castors. Eliminates need for hazardous patient transfers; reduces clinician ergonomic strain. Tested to BSEN1570:1999 standards for dynamic/static load capacity.
Clinical Evidence
Bench testing only. Device performance validated against BSEN1570:1999 requirements, including full dynamic tests at rated load (594lb), 10-minute sink determination under load, 10% overload dynamic testing, and static testing at 25% increased load.
Technological Characteristics
Steel fabrication; electrical linear drive; 24v battery/power supply; adjustable backrest (worm and wheel mechanism) and headrest; pressure-sensitive mat and guarding for foot crush protection; mobile via air cushion pads or ball castors; 45-degree max tilt; 594lb rated capacity per BSEN1570:1999.
Indications for Use
Indicated for patients in wheelchairs requiring medical or dental procedures where transfer from the wheelchair is contraindicated or presents health and safety risks. Suitable for use in clinical settings by healthcare professionals.
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.
Predicate Devices
- Convertible I-series Positioning and Transfer Chair (K071793)
- Electronic Positioning Chair (K001937)
- Dental Tilting Ramp (pre-1976)
- Rehabilitation Hospital Philadelphia Recliner (pre-1976)
