(46 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Chair. P23 is an indoor / outdoor power chair that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the power chair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for - transport and is provided with an onboard battery charger.
The provided text is a 510(k) Summary for a medical device (HEARTWAY Power Chair, P23) and does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria based on metrics like sensitivity, specificity, or reader performance. This document focuses on demonstrating substantial equivalence to a previously marketed device rather than providing a performance study with acceptance criteria for algorithm-based or diagnostic devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them because the document describes a wheelchair, not a diagnostic or AI-driven device that would typically have such performance metrics. The "Performance Testing" section lists EMC reports and compliance with standards for electrically powered wheelchairs, which are safety and electrical compatibility tests, not clinical performance metrics.
However, I can extract information related to the substantial equivalence comparison:
Substantial Equivalence Comparison Summary:
The HEARTWAY Power Chair, P23 is compared to the HEARTWAY Attendant-Controlled Power Chair, TCI (K071006) for substantial equivalence.
Key Similarities (used as evidence for substantial equivalence):
- Intended Use: Both devices provide mobility to persons restricted to a seated position for medical purposes.
- Mainframes: Both devices have folded mainframes, meet strength and fatigue tests using the same material aspects.
- Physical Specifications: Same weight limit, cruising range, suspension of cross brace, size of rear wheels, footplates, armrest type, and warranty.
- Upholstery: Back upholstery material is the same fabric and passed ignition resistance tests.
- Electronic Systems: Electronic systems (controller, batteries, switches, switching power supplies) are from the same suppliers and are UL certificated, ensuring the same safety level.
Key Differences (considered minor for substantial equivalence):
- Control Method: Predicate device is attendant-controlled; new device is designed for general user control. (This is the primary functional difference).
- Physical Dimensions: Minor differences in overall dimension, wheelchair weight, size of front wheels and seat.
- Performance Specifications: Minor differences in incline capabilities, ground clearance, and curb climbing ability (as specified in the User's Manual).
The FDA determined that the device is substantially equivalent to legally marketed predicate devices, subject to general controls.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).