(34 days)
The intended use of the subject device as well as the predicate device empowers physically challenged persons a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to arthritis, paraplegic, multiple sclerosis, and other debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
Manual Wheelchair
This document is a marketing clearance letter from the FDA for a manual wheelchair and does not contain the requested information regarding acceptance criteria, study details, or ground truth establishment for an AI/ML device. Therefore, I cannot provide the specific details you've asked for.
The letter states that the device, a "Manual Wheelchair," has been found "substantially equivalent" to predicate devices marketed before May 28, 1976. This classification (Regulatory Class: I) means it falls under general controls and does not require extensive clinical studies or performance data like those expected for novel or higher-risk devices, especially AI/ML-driven ones.
The information provided is primarily administrative and regulatory, confirming the device's clearance for market based on its similarity to existing manual wheelchairs, not on meeting specific performance metrics derived from a study as would be described for an AI/ML product.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).