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United States·US-MF-000042753
Last updated September 17, 2026
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From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 3003, 9th Avenue SW, Watertown, United States
- —
- facebook.com/pivotalhealthsolutions
- [email protected]
- Phone
- —
- PRRC Contact
- Julee Driver
- EUDAMED SRN
- US-MF-000042753
- FDA FEI Number
- 3003365828
- DUNS Number
- —
Catalogue (80)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Treatment Table | ET106 | FDA UDI | Class I | Active |
| MAX Adjustment Table | Z2051 | FDA UDI | Class I | Active |
| Electric Treatment Table | ET102 | FDA UDI | Class I | Active |
| Decompression of Choice | E9011 | FDA UDI | Class II | Active |
| Bariatric Hi-Lo Mat Table | PT2001 | FDA UDI | Class I | Active |
| Decompression of Choice | E9022-e | FDA UDI | Class II | Active |
| Tradeflex Max | E9118 | FDA UDI | Class I | Active |
| Electric Treatment Table | ET101 | FDA UDI | Class I | Active |
| Tradeflex Flexion Table | E9018-L | FDA UDI | Class I | Active |
| Apollo | Portable, AP2-PT | FDA UDI | Class II | Active |
| Roller Massage Table | TR1000 | FDA UDI | Class I | Active |
| iTrac | T9010 | FDA UDI | Class I | Active |
| Treatment Table | ET108 | FDA UDI | Class I | Active |
| Thera-P | PT9020 | FDA UDI | Class I | Active |
| Ergostyle FX | ES5822 | FDA UDI | Class I | Active |
| Ergostyle HYLO | EH9510 | FDA UDI | Class I | Active |
| Roller Massage Table | ATT-300 | FDA UDI | Class I | Active |
| Apollo | Desktop AP2-DT | FDA UDI | Class II | Active |
| Electric Epidural Positioning Device | EEPD100 | FDA UDI | Class I | Active |
| Elevating Changing Table | A4327-3052EL | FDA UDI | Class I | Active |
| Bariatric Hi-Lo Mat Table | PT2000 | FDA UDI | Class I | Active |
| Tradeflex Flexion Table | E9218-L | FDA UDI | Class I | Active |
| Parallel Bars Electric Platform Mount | EPB10010B | FDA UDI | Class I | Active |
| Electric Treatment Table | ET100 | FDA UDI | Class I | Active |
| Tradeflex Flexion Table | E9018 | FDA UDI | Class I | Active |
| Electric Treatment Table | ET103 | FDA UDI | Class I | Active |
| Tradebasic Adjustment Table | EB9070 | FDA UDI | Class I | Active |
| Tradeflex Flexion Table | E9017-L | FDA UDI | Class I | Active |
| Trademark Elevating Table | E9012-L | FDA UDI | Class I | Active |
| EB Portable Chiropractic Table | PCT1000 | FDA UDI | Class I | Active |
| Thera-P | PT9028 | FDA UDI | Class I | Active |
| Parallel Bars Electric Platform Mount | EPB10012 | FDA UDI | Class I | Active |
| HYLO IAT Elevating Table | HY2002 | FDA UDI | Class I | Active |
| Quantum Intersegmental Table | Q400 | FDA UDI | Class I | Active |
| Essential Pelvic Health Table | EPT9045 | FDA UDI | Class I | Active |
| Trademark Elevating Table | E9212-L | FDA UDI | Class I | Active |
| Treatment Table | ET109 | FDA UDI | Class I | Active |
| Treatment Table | ET107 | FDA UDI | Class I | Active |
| Bariatric Exam Table | ME2001 | FDA UDI | Class I | Active |
| Thera-Ptx | PTX-9040 | FDA UDI | Class I | Active |
| Quantum Intersegmental Table, with Patient Assist | Q400P | FDA UDI | Class I | Active |
| iTrac | T9000 | FDA UDI | Class I | Active |
| Decompression of Choice | E9015-e | FDA UDI | Class II | Active |
| Electric Treatment Table | ET104 | FDA UDI | Class I | Active |
| Changing Table | A4327-3052ADA | FDA UDI | Class I | Active |
| Parallel Bars Electric Platform Mount | EPB10080B | FDA UDI | Class I | Active |
| Ergostyle FX | ES5820 | FDA UDI | Class I | Active |
| Treatment Table | ET105 | FDA UDI | Class I | Active |
| Decompression of Choice | E9011-e | FDA UDI | Class II | Active |
| ErgoTherapy | EGPT | FDA UDI | Class I | Active |
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 9, 2025 | Z-0587-2026 | — | open, classified | The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion. |
| Oct 9, 2025 | Z-0588-2026 | — | open, classified | The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion. |
| Apr 29, 2024 | Z-2326-2024 | — | open, classified | This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the faulty E7130-B part that were manufactured, but had not been distributed yet. |
| Dec 17, 2014 | Z-1250-2015 | — | terminated | Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. These units were manufactured prior to Pivotal Health Solutions acquisition of the Apollo product line. |