21 CFR 890.3850 — Wheelchair, Mechanical
Physical Medicine (PM) · Part 890 Subpart D—Physical Medicine Prosthetic Devices · § 890.3850
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.
Classification Rationale
Class I (general controls).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IOR | Wheelchair, Mechanical | 1 | 454 | 3rd Party |
| LBE | Stroller, Adaptive | 1 | 8 | 3rd Party |
