JAZZY 600— 510(k) K042612
Substantially EquivalentPride Mobility Products Corp.
FDA 510(k) clearance K042612 for JAZZY 600, Substantially Equivalent on 2004-10-06. Applicant: Pride Mobility Products Corp.. Device class: 2.
Clearance details
- Applicant
- Pride Mobility Products Corp.
- Product code
- Code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Exeter, PA, US
Recent devices under product code ITI
view allMore clearances from Pride Mobility Products Corp.
view allAdverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K042612
K-number listed on FDA's recall record- Z-2845-2026 — Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
- Z-2846-2026 — Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042612.
Data sourced from openFDA. This site is unofficial and independent of the FDA.