21 CFR 890.3900 — Wheelchair, Standup
Physical Medicine (PM) · Part 890 Subpart D—Physical Medicine Prosthetic Devices · § 890.3900
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IPL | Wheelchair, Standup | 2 | 66 | 3rd Party |