510(k) K112815 ยท ITI Wheelchair, Powered
QUANTUM BARIATRIC 451
| Applicant | Pride Mobility Product Corporration, Exeter PA, US |
| Decision | Substantially Equivalent, Feb 29, 2012 |
| Received | Sep 27, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112815
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Quantum Outback
Model/Catalog Number: Quantum Outback
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Com Open, Classified |
ITI | None listed |
| Jul 31, 2026 | Pride Mobility Products Corp. Brand Name: Quantum Rehab
Product Name: Quantum 1450
Model/Catalog Number: Quantum 1450
Software Version: 2.0.11, new version: 2.0.13
Product Description: Wheelchair, Powered (ITI), 890.3860
Component Open, Classified |
ITI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.