Components, Wheelchair
FDA product code KNN · Class I (low risk) · 21 CFR 890.3920 · Physical Medicine
64510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Pin Dot Products, Inc. 10
- Berkeley Electric Wheelchair Co. 5
- Fred Sammons, Inc. 4
- Rolcontrol Products, Co., Inc. 4
- Foley & Lardner 4
- Labac Systems, Inc. 3
- Special Health Systems, Ltd. 3
- Mednet, Inc. 1
- E.Z. Lock, Inc. 1
- Professional Service Unltd. 1
- Gaymar Industries, Inc. 1
- Van-Tec, Inc. 1
- Redman, Inc. 1
- Cook Urological, Inc. 1
- Medical Restraints, Inc. 1
- Reloke Co. 1
- Comfortex, Inc. 1
- Kinetic Innovative Seating System, LLC 1
- Electro-Catheter Corp. 1
- Pb Sales C/O Geller & Bozeman 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K211919 | KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKNN · Traditional | Kinetic Innovative Seating System, LLC | 03/04/2022SE |
| K942311 | Dynasty U1-33 AgmKNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942310 | Dynasty GC 12550 (Gell/Cell)KNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942309 | Dynasty U1-31 (Gell/Cell)KNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942308 | Dynasty GC 12400 (Gell/Cell)KNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942312 | Alden Lineage Wheelchair CushionKNN · Traditional | Lewis W. Ward | 05/26/1994SE |
| K942260 | Alden Wheelchair CushionKNN · Traditional | Ward and Assoc. | 05/26/1994SE |
| K933051 | Zero Gravity Wheelchair Components, ModificationKNN · Traditional | General Components Intl., Inc. | 10/12/1993SE |
| K925980 | PMKNN · Traditional | Pathfinder Intl. Corp. | 03/24/1993SE |
| K923942 | Rhombo Medical Rhombo-FillKNN · Traditional | International Medical Products, Inc. | 03/24/1993SE |
| K923364 | Tilt Adjustable Sliding Back Recline Seating SystKNN · Traditional | Labac Systems, Inc. | 03/22/1993SE |
| K925336 | Valu-Plus PadKNN · Traditional | Valmed, Inc. | 02/12/1993SE |
| K923366 | Tilt Seating SystemKNN · Traditional | Labac Systems, Inc. | 02/12/1993SE |
| K923186 | Nexus Wheelchair Cushion/Formerly BiothoticKNN · Traditional | Roho, Inc. | 09/09/1992SE |
| K921369 | Biomedical Horizons Model 1001KNN · Traditional | Biomedical Horizons, Inc. | 05/11/1992SE |
| K921027 | Manual Chair BaseKNN · Traditional | Labac Systems, Inc. | 03/20/1992SE |
| K915629 | Cushion, Whelchar and FlotationKNN · Traditional | Invacare Corp. | 01/09/1992SE |
| K915368 | Serena Wheelchair CushionsKNN · Traditional | A & C Medical Supply | 12/20/1991SE |
| K913553 | Pin Dot Growth/Dial LinksKNN · Traditional | Pin Dot Products, Inc. | 09/05/1991SE |
| K913550 | Pin Dot Trunion MountsKNN · Traditional | Pin Dot Products, Inc. | 09/05/1991SE |
| K913549 | Pin Dot Mounting BracketsKNN · Traditional | Pin Dot Products, Inc. | 09/05/1991SE |
| K913548 | Pin Dot Aluminum PanKNN · Traditional | Pin Dot Products, Inc. | 09/05/1991SE |
| K913546 | Impala CastersKNN · Traditional | Pin Dot Products, Inc. | 09/05/1991SE |
| K913545 | Pin Dot Flip-Down AbductorKNN · Traditional | Pin Dot Products, Inc. | 09/05/1991SE |
| K913511 | Impala AxlesKNN · Traditional | Pin Dot Products, Inc. | 09/05/1991SE |
| K913509 | Impala WheelsKNN · Traditional | Pin Dot Products, Inc. | 09/05/1991SE |
| K913507 | ArmrestKNN · Traditional | Pin Dot Products, Inc. | 09/05/1991SE |
| K913552 | Pin Dot Footrest ProductsKNN · Traditional | Pin Dot Products, Inc. | 08/29/1991SE |
| K905013 | T.C.S. Total Contact SeatKNN · Traditional | Fundamental Products Co. | 12/19/1990SE |
| K904913 | Handi-Trak Wheelchair Snow ChainsKNN · Traditional | Handi-Trak, Inc. | 11/07/1990SE |
| K900839 | The Carolina RockerKNN · Traditional | Artec Environmental Monitoring Division | 04/18/1990SE |
| K894770 | Personal Back with Fip KitKNN · Traditional | Canadian Posture and Seating Centre, Inc. | 09/11/1989SE |
| K890178 | Wheelchair Stump SupportKNN · Traditional | Gerber Chair Mates, Inc. | 09/11/1989SE |
| K894960 | E.Z. Lock Wheelchair Restraint DeviceKNN · Traditional | E.Z. Lock, Inc. | 09/05/1989SE |
| K885106 | Removable Battery Power SystemKNN · Traditional | Rolcontrol Products, Co., Inc. | 12/27/1988SE |
| K885105 | Sliding Arm SupportKNN · Traditional | Rolcontrol Products, Co., Inc. | 12/27/1988SE |
| K885104 | Laydown Arm Support MechanismKNN · Traditional | Rolcontrol Products, Co., Inc. | 12/27/1988SE |
| K884052 | Gillum's Wheelchair Width Reducing AttachmentKNN · Traditional | Professional Service Unltd. | 10/26/1988SE |
| K883679 | Wheels-Off Quick Release Axle SystemKNN · Traditional | Rolcontrol Products, Co., Inc. | 09/13/1988SE |
| K882253 | Stoute's Assist-Seat Wheelchair ComponentKNN · Traditional | Stoute'S "Assist-Seat" Corp. | 06/27/1988SE |
| K882012 | Lifestyle Sof. Care Gel Chair CushionKNN · Traditional | Gaymar Industries, Inc. | 05/23/1988SE |
| K870698 | Van-Tec Prostate Biopsy NeedleKNN · Traditional | Van-Tec, Inc. | 03/25/1987SE |
| K870299 | Redman Upholstery Series for WheelchairsKNN · Traditional | Redman, Inc. | 02/10/1987SE |
| K863385 | (Roth)Spiral Rotating Prostatic Biopsy NeedleKNN · Traditional | Cook Urological, Inc. | 11/04/1986SE |
| K862887 | Upholstered Bucket SeatKNN · Traditional | Mednet, Inc. | 08/14/1986SE |
| K861755 | SHS Cushion/WheelchairKNN · Traditional | Special Health Systems, Ltd. | 05/23/1986SE |
| K861754 | Kinesethetic Seating System/WheelchairKNN · Traditional | Special Health Systems, Ltd. | 05/23/1986SE |
| K861751 | The Fitz Kit, Molded/Custom Wheelchair Seating SysKNN · Traditional | Special Health Systems, Ltd. | 05/23/1986SE |
| K854710 | Bottoms-Up TM Pelvic Spinal Posture-AidKNN · Traditional | Reloke Co. | 04/16/1986SN |
| K855181 | Comfortex Wheelchair CushionKNN · Traditional | Comfortex, Inc. | 01/13/1986SE |
| K840629 | Wheelchair AccessoriesKNN · Traditional | Poirier S.A. | 02/27/1984SE |
| K823638 | Arm Through for Wheelchair BK 6454-01 &KNN · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823637 | Arm Through for Wheelchair BK-6458-01KNN · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823877 | Berkeley HarnessKNN · Traditional | Berkeley Electric Wheelchair Co. | 01/14/1983SE |
| K823876 | Berkeley ForkKNN · Traditional | Berkeley Electric Wheelchair Co. | 01/14/1983SE |
| K823875 | Chain KitKNN · Traditional | Berkeley Electric Wheelchair Co. | 01/14/1983SE |
| K823874 | Berkeley BrakeKNN · Traditional | Berkeley Electric Wheelchair Co. | 01/14/1983SE |
| K823873 | Chain SilencerKNN · Traditional | Berkeley Electric Wheelchair Co. | 01/14/1983SE |
| K821488 | Elecath Portal Vein/Biliary Drain AssmKNN · Traditional | Electro-Catheter Corp. | 05/28/1982SE |
| K820761 | Palm Beach Seating SystemKNN · Traditional | Pb Sales C/O Geller & Bozeman | 04/21/1982SE |
| K813636 | BK-6470 Adjustable Elevating WheelchairKNN · Traditional | Fred Sammons, Inc. | 01/19/1982SE |
| K812348 | Desk Arm Wheelchair Arm ExtensionKNN · Traditional | Fred Sammons, Inc. | 09/11/1981SE |
| K780192 | Legrest, ElevatingKNN · Traditional | Orthopedic Equipment Co., Inc. | 02/14/1978SE |
| K771631 | Wheelchair Safety BeltKNN · Traditional | Medical Restraints, Inc. | 09/12/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2856-2026 Class II | munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control…A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs… | Munevo GmbH | 06/19/2026Open, Classified |
| Z-2459-2025 Class I | IDM-ARLITE-R. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which… | mo-Vis BVBA | 07/10/2025Open, Classified |
| Z-2458-2025 Class I | All-round Joystick R-net Light. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which… | mo-Vis BVBA | 07/10/2025Open, Classified |
| Z-2457-2025 Class I | IDM-MULTI-R. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which… | mo-Vis BVBA | 07/10/2025Open, Classified |
| Z-2456-2025 Class I | IDM-MICRO-R. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which… | mo-Vis BVBA | 07/10/2025Open, Classified |
| Z-2455-2025 Class I | Multi Joystick R-net. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which… | mo-Vis BVBA | 07/10/2025Open, Classified |
| Z-2454-2025 Class I | Micro Joystick R-net. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which… | mo-Vis BVBA | 07/10/2025Open, Classified |
| Z-0713-2024 Class II | Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a…In rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come… | mo-Vis BVBA | 11/28/2023Open, Classified |
| Z-2594-2023 Class II | SofTech Pressure-Sensing Wheelchair CushionsDefective battery pack in wheelchair cushions can overheat resulting in property damage and one possible… | Aquila Corporation | 07/06/2023Open, Classified |
| Z-2593-2023 Class II | APK2 Pressure-Sensing Wheelchair CushionsDefective battery pack in wheelchair cushions can overheat resulting in property damage and one possible… | Aquila Corporation | 07/06/2023Open, Classified |
| Z-1278-2012 | Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking deviceThe fasteners used between June 3, 2011 and January 31, 2012 to attach the Permolock C3 pins to wheelchairs… | Permobil Inc | 02/21/2012Terminated |