510(k) K213043 ยท IPF Stimulator, Muscle, Powered
Levator Elite (Model LE9011)
| Applicant | Shenzhen Dongdixin Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Feb 25, 2022 |
| Received | Sep 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213043
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.