510(k) K252849 · BYI Percussor, Powered-Electric
AffloVest® Mobile Airway Clearance Therapy
| Applicant | Tactile Medical, Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 30, 2026 |
| Received | Sep 8, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252849
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.