PCI CUSTOM DESIGN SERIES
Device Facts
| Record ID | K861943 |
|---|---|
| Device Name | PCI CUSTOM DESIGN SERIES |
| Applicant | Poston & Cole Intl. |
| Product Code | IQC · Physical Medicine |
| Decision Date | May 30, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3880 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A special grade wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is intended to be used in all environments for long-term use, e.g., for paraplegics, quadraplegics, and amputees.
