510(k) K101889 ยท ITH Equipment, Traction, Powered
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
| Applicant | Pivotal Health Solutions, Watertown SD, US |
| Decision | Substantially Equivalent, Aug 27, 2010 |
| Received | Jul 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101889
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2024 | Pivotal Health Solutions, Inc. Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment. Open, Classified |
ITH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.