Mechanical Wheelchair
FDA 510(k) K120302 · Novaf Andalucia 2007, SL
510(k) numberK120302
Submission
- Device name
- Mechanical Wheelchair
- Applicant
- Novaf Andalucia 2007, SL
Rota, ES - Received
- February 1, 2012
- Decision date
- July 6, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| 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 Mechanical Wheelchair cleared by the FDA?
Mechanical Wheelchair (K120302) received a 510(k) decision of Substantially Equivalent on July 6, 2012, 156 days after the submission was received.
What is the product code of K120302?
The FDA product code is IQC – Wheelchair, Special Grade, a Class II (moderate risk) device regulated under 21 CFR 890.3880.