(100 days)
The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander and brings the user from a seated position to a passive standing position.
The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander and brings the user from a seated position to a passive standing position.
This FDA 510(k) clearance letter for the Tek RMD (Robotic Mobilization Device) does not contain specific details about acceptance criteria, device performance results, or a detailed study description as typically found in an AI/ML device submission summary.
The document is a clearance letter from the FDA to Matia Robotics, indicating that their device has been found substantially equivalent to a legally marketed predicate device. This type of document confirms regulatory clearance but does not delve into the granular technical details of performance evaluation for AI/ML devices.
Therefore, the requested information cannot be extracted from the provided text. To answer your questions, one would need to access the actual 510(k) submission summary for K15058, which would contain the performance study details.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).