510(k) K253001 ยท NHJ Device, Positive Pressure Breathing, Intermittent
KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)
| Applicant | Hunan Ruijiong Biotech Co., Ltd., Xiangtan, CN |
| Decision | Substantially Equivalent, Jun 16, 2026 |
| Received | Sep 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253001
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.