Company ยท US
Pivotal Health Solutions
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2014. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
4recalls (2 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2025 | Pivotal Health Solutions, Inc. Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table Open, Classified |
ISA | None listed |
| Nov 24, 2025 | Pivotal Health Solutions, Inc. Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table Open, Classified |
ISA | None listed |
| 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 | K101889 |
| Mar 6, 2015 | Pivotal Health Solutions Apollo (cold) Laser Desktop Control Units, Model AP2-DT.
The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tis Terminated |
ILY | K060134 |