(31 days)
- Children who are unable to walk or who have a walking impediment.
Manual Wheelchair
The provided text is a 510(k) summary for the Otto Bock Start Junior manual wheelchair and does not contain information about acceptance criteria, device performance metrics, or details of any studies (such as sample sizes, expert qualifications, or ground truth establishment) typically associated with software or AI/ML-based medical devices.
The document primarily focuses on:
- Administrative information: Submitter's name, address, contact, date prepared, registration number.
- Device identification: Name, trade name, common name, classification name, product code, class, regulation number.
- FDA communication: Confirmation of substantial equivalence to a predicate device, regulatory class, and general controls provisions.
- Indications for Use: Children who are unable to walk or who have a walking impediment.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text. This document is a regulatory submission for a physical medical device (manual wheelchair), not a software device, and thus the requested AI/ML specific information is irrelevant to this submission.
§ 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).