510(k) K042612 ยท ITI Wheelchair, Powered
JAZZY 600
| Applicant | Pride Mobility Products Corp., Exeter PA, US |
| Decision | Substantially Equivalent, Oct 6, 2004 |
| Received | Sep 24, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042612
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2026 | Pride Mobility Products Corp. 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: Co Open, Classified |
ITI | None listed |
| Jul 31, 2026 | Pride Mobility Products Corp. 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: Open, Classified |
ITI | None listed |
| Sep 29, 2010 | Pride Mobility Products Corp Jazzy Select 6 with XLR Port Harness Terminated |
ITI | None listed |
| Aug 27, 2008 | Pride Mobility Products Corp Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107 Terminated |
ITI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.