Wheelchair, Special Grade
A special grade wheelchair is a wheelchair designed for specific clinical or environmental needs beyond standard configurations, such as those used in institutional or bariatric settings. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IQC, regulated under 21 CFR 890.3880, within the Physical Medicine medical specialty. This device is eligible for third party 510(k) review.
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Basic Information
- Product Code
- IQC
- Device Class
- FDA class 2
- Regulation Number
- 890.3880
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 24 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251570 | Hippocampe Marathon and Trail | Jun 23, 2025 | Substantially Equivalent | Vipamat Sarl |
| K120302 | MECHANICAL WHEELCHAIR | Jul 06, 2012 | Substantially Equivalent | Novaf Andalucia 2007, SL |
| K082857 | RENEGADE WHEELCHAIR | Jan 06, 2009 | Substantially Equivalent | Alpha One |
| K051709 | HIPPOCAMPE WHEELCHAIR | Aug 15, 2005 | Substantially Equivalent | Vipamat Technologie |
| K895384 | CALIFORNIA COMFORT FOUR WHEEL | Sep 18, 1989 | Substantially Equivalent | Jubilee Scooters, Inc. |
| K861943 | PCI CUSTOM DESIGN SERIES | May 30, 1986 | Substantially Equivalent | Poston & Cole Intl. |
| K843213 | QUALINE WHEELCHAIR PRODUCTS | Aug 24, 1984 | Substantially Equivalent | Contemporary Health Sys |
| K842719 | STANDARD WHEELCHAIR | Jul 25, 1984 | Substantially Equivalent | Greene International Corp. |
| K840636 | CHILDREN'S WHEELCHAIRS | Feb 27, 1984 | Substantially Equivalent | Poirier S.A. |
| K840635 | TRAINING WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent | Poirier S.A. |
| K840634 | OLYMPIC & BASKET WHEELCHAIRS | Feb 27, 1984 | Substantially Equivalent | Poirier S.A. |
| K840632 | HEMIPLEGIC WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent | Poirier S.A. |
| K840631 | ARNAS WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent | Poirier S.A. |
| K840630 | POIRIER REGLADE WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent | Poirier S.A. |
| K840628 | LARGE FRONT WHEELS WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent | Poirier S.A. |
| K840627 | AMPUTEE WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent | Poirier S.A. |
| K840625 | UNION WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent | Poirier S.A. |
| K840234 | POIRIER VARIABLE WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent | Poirier S.A. |
| K834498 | TRAIL CHAIR | Jan 30, 1984 | Substantially Equivalent | Winchester Industries, Inc. |
| K832322 | BASE ONLY, TORONTO CHAIR | Aug 12, 1983 | Substantially Equivalent | Intl. Medical Equipment Corp. |
| K831510 | FREEDOM 19 RECREATIONAL WHEELCHAIR | Jul 19, 1983 | Substantially Equivalent | Carbonite Corp. |
| K801317 | QUADRA WHEELCHAIR, QUADRA CHAIR, ETC. | Jul 21, 1980 | Substantially Equivalent | Quadra Wheelchairs, Inc. |
| K770147 | AVON TILTING PUSH CHAIR 14 | Feb 02, 1977 | Substantially Equivalent | Maddak, Inc. |
| K770145 | YORKHILL CHAIR | Jan 28, 1977 | Substantially Equivalent | Maddak, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.