| Primary Device ID | 00850020142422 |
| NIH Device Record Key | b3c6c28f-e203-4e6c-88b8-9e720786552e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantum Intersegmental Table, with Patient Assist |
| Version Model Number | Q400P |
| Company DUNS | 826316098 |
| Company Name | PIVOTAL HEALTH SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850020142422 [Primary] |
| ISA | Massager, Therapeutic, Electric |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-29 |
| Device Publish Date | 2023-08-21 |
| 00854798000274 - THERA-PTX | 2024-07-24 |
| 00854798000281 - THERA-PTX | 2024-07-24 |
| 00850020142415 - Quantum Intersegmental Table | 2023-08-29 |
| 00850020142422 - Quantum Intersegmental Table, with Patient Assist | 2023-08-29 |
| 00850020142422 - Quantum Intersegmental Table, with Patient Assist | 2023-08-29 |
| 00854798000007 - Pelvic Health Table | 2023-08-29 |
| 00854798000038 - Essential Pelvic Health Table | 2023-08-29 |
| 00854798000045 - Tradeflex Max | 2023-08-29 |
| 00854798000052 - Tradeflex Max, Elevating | 2023-08-29 |