510(k) K253055 · GYD Transducer, Tremor
Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW)
| Applicant | Nordic Kinetics AB, Lund, SE |
| Decision | Substantially Equivalent, Jun 17, 2026 |
| Received | Sep 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253055
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.