(134 days)
Provide mobility to persons physically challenged and limited to sitting positions due to:
- Palsies/Paralyses .
- Loss of limbs
- Defective and/or deformed limbs ●
- Joint contractures .
- Joint defects ●
- . Other diseases
The z10 is a powerful push and brake assist for manual wheelchairs. It can also be converted into the z10-ce add-on drive with tiller control quickly and easily. In this product version, the user drives and controls the wheelchair independently.
I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.
The document is a 510(k) summary for a physical medical device, the "z10 Push and Brake Assist," which is a powered wheelchair mover. The safety testing mentioned refers to physical product standards compliance (e.g., ISO, ANSI/RESNA) for a hardware device, not performance metrics for an AI system.
Therefore, I cannot provide the requested information, as it is not present in the given document.
§ 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).