510(k) K213533 ยท IRP Massager, Powered Inflatable Tube
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
| Applicant | Bio Compression Systems, Inc., Moonachie NJ, US |
| Decision | Substantially Equivalent, Feb 16, 2022 |
| Received | Nov 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213533
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.