Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart D — Physical Medicine Prosthetic Devices](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices) → [21 CFR 890.3880](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3880) → IQC — Wheelchair, Special Grade # IQC · Wheelchair, Special Grade _Physical Medicine · 21 CFR 890.3880 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC ## Overview - **Product Code:** IQC - **Device Name:** Wheelchair, Special Grade - **Regulation:** [21 CFR 890.3880](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3880) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) - **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](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K251570.md) | Hippocampe Marathon and Trail | Vipamat Sarl | Jun 23, 2025 | SESE | | [K120302](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K120302.md) | MECHANICAL WHEELCHAIR | Novaf Andalucia 2007, SL | Jul 6, 2012 | SESE | | [K082857](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K082857.md) | RENEGADE WHEELCHAIR | Alpha One | Jan 6, 2009 | SESE | | [K051709](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K051709.md) | HIPPOCAMPE WHEELCHAIR | Vipamat Technologie | Aug 15, 2005 | SESE | | [K895384](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K895384.md) | CALIFORNIA COMFORT FOUR WHEEL | Jubilee Scooters, Inc. | Sep 18, 1989 | SESE | | [K861943](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K861943.md) | PCI CUSTOM DESIGN SERIES | Poston & Cole Intl. | May 30, 1986 | SESE | | [K843213](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K843213.md) | QUALINE WHEELCHAIR PRODUCTS | Contemporary Health Sys | Aug 24, 1984 | SESE | | [K842719](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K842719.md) | STANDARD WHEELCHAIR | Greene International Corp. | Jul 25, 1984 | SESE | | [K840636](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K840636.md) | CHILDREN'S WHEELCHAIRS | Poirier S.A. | Feb 27, 1984 | SESE | | [K840635](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K840635.md) | TRAINING WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE | | [K840634](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K840634.md) | OLYMPIC & BASKET WHEELCHAIRS | Poirier S.A. | Feb 27, 1984 | SESE | | [K840632](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K840632.md) | HEMIPLEGIC WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE | | [K840631](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K840631.md) | ARNAS WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE | | [K840630](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K840630.md) | POIRIER REGLADE WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE | | [K840628](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K840628.md) | LARGE FRONT WHEELS WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE | | [K840627](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K840627.md) | AMPUTEE WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE | | [K840625](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K840625.md) | UNION WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE | | [K840234](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K840234.md) | POIRIER VARIABLE WHEELCHAIR | Poirier S.A. | Feb 27, 1984 | SESE | | [K834498](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K834498.md) | TRAIL CHAIR | Winchester Industries, Inc. | Jan 30, 1984 | SESE | | [K832322](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC/K832322.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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