510(k) K080385 ยท ITI Wheelchair, Powered
CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR
| Applicant | E1 Ent., Inc., Pompano Beach FL, US |
| Decision | Substantially Equivalent, May 13, 2008 |
| Received | Feb 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080385
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.