Qualine Wheelchair Products
FDA 510(k) K843213 · Contemporary Health Sys
510(k) numberK843213
Submission
- Device name
- Qualine Wheelchair Products
- Applicant
- Contemporary Health Sys
Mchenry, IL, US - Received
- August 15, 1984
- Decision date
- August 24, 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
Other 510(k)s with product code IQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K842719 | Standard WheelchairIQC · Traditional | Greene International Corp. | 07/25/1984SE |
| 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 |
Questions and answers
When was Qualine Wheelchair Products cleared by the FDA?
Qualine Wheelchair Products (K843213) received a 510(k) decision of Substantially Equivalent on August 24, 1984, 9 days after the submission was received.
What is the product code of K843213?
The FDA product code is IQC – Wheelchair, Special Grade, a Class II (moderate risk) device regulated under 21 CFR 890.3880.