(93 days)
Walking rehabilitation training electric wheelchair is to provide indoor mobility, including stand-up feature, to persons limited to a seating position that are capable of operating a powered wheelchair.
Walking rehabilitation training electric wheelchair (ZW518)
This FDA 510(k) clearance letter for the "Walking rehabilitation training electric wheelchair (ZW518)" does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a regulatory clearance letter, confirming that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance, labeling, quality systems, and other administrative requirements for marketing the device.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- Method for establishing training set ground truth.
This document pertains to the regulatory pathway for market clearance, not the detailed technical and performance validation studies.
§ 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).