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 890.3920](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3920) → KNN — Components, Wheelchair # KNN · Components, Wheelchair _Physical Medicine · 21 CFR 890.3920 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN ## Overview - **Product Code:** KNN - **Device Name:** Components, Wheelchair - **Regulation:** [21 CFR 890.3920](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3920) - **Device Class:** 1 - **Review Panel:** [Physical Medicine](/submissions/PM) ## Identification A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. ## Recent Cleared Devices (20 of 64) Showing 20 most recent of 64 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K211919](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K211919.md) | KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat | Kinetic Innovative Seating System, LLC | Mar 4, 2022 | SESE | | [K942311](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K942311.md) | DYNASTY U1-33 AGM | Foley & Lardner | Nov 7, 1994 | SESE | | [K942310](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K942310.md) | DYNASTY GC 12550 (GELL/CELL) | Foley & Lardner | Nov 7, 1994 | SESE | | [K942309](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K942309.md) | DYNASTY U1-31 (GELL/CELL) | Foley & Lardner | Nov 7, 1994 | SESE | | [K942308](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K942308.md) | DYNASTY GC 12400 (GELL/CELL) | Foley & Lardner | Nov 7, 1994 | SESE | | [K942312](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K942312.md) | ALDEN LINEAGE WHEELCHAIR CUSHION | Lewis W. Ward | May 26, 1994 | SESE | | [K942260](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K942260.md) | ALDEN WHEELCHAIR CUSHION | Ward and Assoc. | May 26, 1994 | SESE | | [K933051](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K933051.md) | ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION | General Components Intl., Inc. | Oct 12, 1993 | SESE | | [K925980](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K925980.md) | PM | Pathfinder Intl. Corp. | Mar 24, 1993 | SESE | | [K923942](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K923942.md) | RHOMBO MEDICAL RHOMBO-FILL | International Medical Products, Inc. | Mar 24, 1993 | SESE | | [K923364](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K923364.md) | TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST | Labac Systems, Inc. | Mar 22, 1993 | SESE | | [K925336](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K925336.md) | VALU-PLUS PAD | Valmed, Inc. | Feb 12, 1993 | SESE | | [K923366](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K923366.md) | TILT SEATING SYSTEM | Labac Systems, Inc. | Feb 12, 1993 | SESE | | [K923186](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K923186.md) | NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC | Roho, Inc. | Sep 9, 1992 | SESE | | [K921369](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K921369.md) | BIOMEDICAL HORIZONS MODEL 1001 | Biomedical Horizons, Inc. | May 11, 1992 | SESE | | [K921027](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K921027.md) | MANUAL CHAIR BASE | Labac Systems, Inc. | Mar 20, 1992 | SESE | | [K915629](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K915629.md) | CUSHION, WHELCHAR AND FLOTATION | Invacare Corp. | Jan 9, 1992 | SESE | | [K915368](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K915368.md) | SERENA WHEELCHAIR CUSHIONS | A & C Medical Supply | Dec 20, 1991 | SESE | | [K913553](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K913553.md) | PIN DOT GROWTH/DIAL LINKS | Pin Dot Products, Inc. | Sep 5, 1991 | SESE | | [K913550](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN/K913550.md) | PIN DOT TRUNION MOUNTS | Pin Dot Products, Inc. | Sep 5, 1991 | SESE | ## Top Applicants - Pin Dot Products, Inc. — 10 clearances - Berkeley Electric Wheelchair Co. — 5 clearances - Foley & Lardner — 4 clearances - Fred Sammons, Inc. — 4 clearances - Rolcontrol Products, Co., Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/KNN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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