(627 days)
Integrated Voice Operated Control system for electric wheelchairs, allows the occupant to control movement of their chair by using voice commands.
Controllers. The user's wheelchair must have one of the following controllers:
A. Invacare MK IV controller. B. Everest and Jennings Z-51 or Z-61 controller. C. Quickie P100, P200, or P300 controller. D. Dynamic Controls Ltd. DX-Power controller. Vocal Capability. The User must have the ability to consistently reproduce a series commands or sounds.
Emergency Stop Switch. The User must have the capability to activate a manual Emergency Stop Switch.
Integrated Voice Operated Control Unit (IVOC-1) for Powered Wheelchairs
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Integrated Voice Operated Control Unit (IVOC-1) for Powered Wheelchairs." This document does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the device was approved based on its substantial equivalence to a predicate device, not on meeting specific, independently defined acceptance criteria or through a clinical study demonstrating performance against such criteria.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval based on substantial equivalence.
§ 890.3920 Wheelchair component.
(a)
Identification. A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops.(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 § 890.9.