Product code MRI
- Device name
- Orthosis, Truncal/Orthosis, Limb
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3490
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00650551006794 | ILSO™ | PMT CORPORATION | 2026-07-18 |
| 00650551006800 | ILSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006961 | ITLSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006954 | ILSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006947 | ITLSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006930 | ITLSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006923 | ITLSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006916 | ITLSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006909 | ITLSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006893 | ITLSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006879 | ITLSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006862 | ILSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006855 | ILSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006848 | ILSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006831 | ILSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006824 | ILSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006817 | ILSO™ | PMT CORPORATION | 2026-07-17 |
| 00650551006886 | ITLSO™ | PMT CORPORATION | 2026-07-17 |
| 00645517017815 | Trulife | Trulife Limited | 2022-12-31 |
| 00645517017808 | Trulife | Trulife Limited | 2022-12-31 |
| 00645517015651 | Trulife | Trulife Limited | 2022-12-31 |
| 00645517015644 | Trulife | Trulife Limited | 2022-12-31 |
| 00645517015637 | Trulife | Trulife Limited | 2022-12-31 |
| 00645517015620 | Trulife | Trulife Limited | 2022-12-31 |
| 00645517015613 | Trulife | Trulife Limited | 2022-12-31 |
| 00616784562537 | Disposable Head Loggs | Dynarex Corporation | 2022-05-04 |
| 00616784562933 | Basic, Quick-Release Head Immobilizer | Dynarex Corporation | 2021-09-01 |
| 00616784562827 | Deluxe Head Immobilizer | Dynarex Corporation | 2021-09-01 |
| 00616784562735 | Cardboard Head Immobilizer | Dynarex Corporation | 2021-09-01 |
| 00616784562636 | Disposable Foam Head Blocks | Dynarex Corporation | 2021-09-01 |