IQC · Wheelchair, Special Grade
Physical Medicine · 21 CFR 890.3880 · Class 2
Overview
| Product Code | IQC |
|---|---|
| Device Name | Wheelchair, Special Grade |
| Regulation | 21 CFR 890.3880 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251570 | Hippocampe Marathon and Trail | Vipamat Sarl | Jun 23, 2025 | SESE |
| K120302 | MECHANICAL WHEELCHAIR | Novaf Andalucia 2007, SL | Jul 6, 2012 | SESE |
| K082857 | RENEGADE WHEELCHAIR | Alpha One | Jan 6, 2009 | SESE |
| K051709 | HIPPOCAMPE WHEELCHAIR | Vipamat Technologie | Aug 15, 2005 | SESE |
| K895384 | CALIFORNIA COMFORT FOUR WHEEL | Jubilee Scooters, Inc. | Sep 18, 1989 | SESE |
| K861943 | PCI CUSTOM DESIGN SERIES | Poston & Cole Intl. | May 30, 1986 | SESE |
| K843213 | QUALINE WHEELCHAIR PRODUCTS | Contemporary Health Sys | Aug 24, 1984 | SESE |
| K842719 | STANDARD WHEELCHAIR | Greene International Corp. | Jul 25, 1984 | SESE |
| K840636 | CHILDREN'S WHEELCHAIRS | Poirier S.A. | Feb 27, 1984 | SESE |
| K840635 | TRAINING WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE |
| K840634 | OLYMPIC & BASKET WHEELCHAIRS | Poirier S.A. | Feb 27, 1984 | SESE |
| K840632 | HEMIPLEGIC WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE |
| K840631 | ARNAS WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE |
| K840630 | POIRIER REGLADE WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE |
| K840628 | LARGE FRONT WHEELS WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE |
| K840627 | AMPUTEE WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE |
| K840625 | UNION WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE |
| K840234 | POIRIER VARIABLE WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE |
| K834498 | TRAIL CHAIR | Winchester Industries, Inc. | Jan 30, 1984 | SESE |
| K832322 | BASE ONLY, TORONTO CHAIR | Intl. Medical Equipment Corp. | Aug 12, 1983 | SESE |
Top Applicants
- Poirier S.A. — 10 clearances
- Maddak, Inc. — 2 clearances
- Alpha One — 1 clearance
- Carbonite Corp. — 1 clearance
- Contemporary Health Sys — 1 clearance
