Standard Wheelchair
FDA 510(k) K842719 · Greene International Corp.
510(k) numberK842719
Submission
- Device name
- Standard Wheelchair
- Applicant
- Greene International Corp.
Mchenry, IL, US - Received
- July 13, 1984
- Decision date
- July 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IQC – Wheelchair, Special Grade
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3880
- Specialty
- Physical Medicine
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|---|---|---|---|
| K251570 | Hippocampe Marathon and TrailIQC · Traditional | Vipamat Sarl | 06/23/2025SE |
| K120302 | Mechanical WheelchairIQC · Traditional | Novaf Andalucia 2007, SL | 07/06/2012SE |
| K082857 | Renegade WheelchairIQC · Traditional | Alpha One | 01/06/2009SE |
| K051709 | Hippocampe WheelchairIQC · Traditional | Vipamat Technologie | 08/15/2005SE |
| K895384 | California Comfort Four WheelIQC · Traditional | Jubilee Scooters, Inc. | 09/18/1989SE |
| K861943 | Pci Custom Design SeriesIQC · Traditional | Poston & Cole Intl. | 05/30/1986SE |
| K843213 | Qualine Wheelchair ProductsIQC · Traditional | Contemporary Health Sys | 08/24/1984SE |
| K840636 | Children's WheelchairsIQC · Traditional | Poirier S.A. | 02/27/1984SE |
| K840635 | Training WheelchairIQC · Traditional | Poirier S.A. | 02/27/1984SE |
| K840634 | Olympic & Basket WheelchairsIQC · Traditional | Poirier S.A. | 02/27/1984SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K883827 | Masks, Various Types of Surgical MasksFXX · Traditional | 11/17/1988SE |
| K883828 | Cone Masks, Various Types of Surgical Cone MasksFXX · Traditional | 10/03/1988SE |
| K880484 | Surgical GarmentsFYC · Traditional | 06/27/1988SE |
| K870617 | Various Tyes of Surgical GarmentsFYF · Traditional | 03/09/1987SE |
| K843075 | Utility Scissors Disposable ItemsJOK · Traditional | 09/05/1984SE |
| K843073 | Fixed Vol. Dispensers, Adjust Vol-HunpipJQW · Traditional | 08/24/1984SE |
| K843074 | Dispos. & Sponge Forceps Pean ArteryGEN · Traditional | 08/17/1984SE |
Questions and answers
When was Standard Wheelchair cleared by the FDA?
Standard Wheelchair (K842719) received a 510(k) decision of Substantially Equivalent on July 25, 1984, 12 days after the submission was received.
What is the product code of K842719?
The FDA product code is IQC – Wheelchair, Special Grade, a Class II (moderate risk) device regulated under 21 CFR 890.3880.