(21 days)
The intended use of Shockwave Suspension Wheelchair is to provide mobility to persons with physical limitations limited to a sitting position.
The intended use of the Shockwave Su:pension Wheelchair is to provide mobility to persons with physical limitations limited to a sitting position. It is intended for indoors and outdoor use by individuals of all as; s who are physically challenged.
Shockwave Suspension Wheelchair is a self-propelled, rigid frame, mechanical wheelchair consisting of components typical of most manual wheelchairs. It has large rear wheels with push rims for self-propulsion and small front pivoting casters for turning and stability. It is a lightweight, user adaptable, everyday chair for use both indoors and outdoors.
This document is a 510(k) summary for a medical device called the "Shockwave Suspension Wheelchair." It is primarily an administrative document for regulatory clearance. As such, it does not contain the detailed technical information typically found in a study report that describes acceptance criteria and how a device meets them.
Therefore, I cannot provide the requested information because the provided text does not include:
- A table of acceptance criteria or reported device performance metrics.
- Details about a study proving the device meets acceptance criteria.
- Sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used, training set sample size, or how ground truth for the training set was established.
The document states that the device is "substantially equivalent" to predicate devices based on "specifications, performance and use." This implies that the device is expected to perform similarly to established devices, but it does not detail the specific performance metrics or studies conducted to demonstrate this equivalence.
§ 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).