510(k) K243572 ยท IRP Massager, Powered Inflatable Tube
Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/W
| Applicant | Avanos Medical, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Jan 31, 2025 |
| Received | Nov 18, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243572
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.