Pivotal Health Solutions, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 2
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0587-2026 | Class II | Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table | October 9, 2025 |
| Z-0588-2026 | Class II | Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table | October 9, 2025 |
| Z-2326-2024 | Class II | Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with pract | April 29, 2024 |
| Z-1250-2015 | Class II | Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intend | December 17, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K131983 | ITRAC CERVICAL TRACTION SYSTEM | September 10, 2014 |
| K101889 | DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE | August 27, 2010 |