(244 days)
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
Not Found
This document is a 510(k) premarket notification approval letter for a medical device, specifically a "Comfort Standing Wheelchair - Hero 1". It primarily addresses the device's substantial equivalence to predicate devices and provides regulatory guidance.
Therefore, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set, data provenance, or details about a test set.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Information about a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Details about a standalone algorithm performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for a training set.
- How ground truth for a training set was established.
§ 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).