Product code IQE
- Device name
- Orthosis, Lumbar
- 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 |
|---|---|---|---|
| 00810041980151 | Vive | VIVE HEALTH LLC | 2024-08-16 |
| 00810041983107 | Vive | VIVE HEALTH LLC | 2024-06-05 |
| 00810041983091 | Vive | VIVE HEALTH LLC | 2024-06-05 |
| 00810041983084 | Vive | VIVE HEALTH LLC | 2024-06-05 |
| 00810041983022 | CoreTech | VIVE HEALTH LLC | 2024-06-05 |
| 00810041983015 | CoreTech | VIVE HEALTH LLC | 2024-06-05 |
| 00810041982681 | Vive | VIVE HEALTH LLC | 2024-06-05 |
| 00810041982674 | Vive | VIVE HEALTH LLC | 2024-06-05 |
| 00810041980304 | CoreTech | VIVE HEALTH LLC | 2023-08-02 |
| 00810113572185 | Vive | VIVE HEALTH LLC | 2023-07-24 |
| 00810113572161 | Vive | VIVE HEALTH LLC | 2023-07-24 |
| 00810113572178 | Vive | VIVE HEALTH LLC | 2023-07-24 |
| 00810113571034 | Vive | VIVE HEALTH LLC | 2023-06-15 |
| 00810113571041 | Vive | VIVE HEALTH LLC | 2023-06-15 |
| 00810113571058 | Vive | VIVE HEALTH LLC | 2023-06-15 |
| 00810113571065 | Vive | VIVE HEALTH LLC | 2023-06-15 |
| 00810113572727 | CoreTech | VIVE HEALTH LLC | 2023-06-15 |
| 00810041980298 | CoreTech | VIVE HEALTH LLC | 2023-06-15 |
| 00057475210465 | BIOS Living | Thermor Ltd | 2023-03-31 |
| 00057475210458 | BIOS Living | Thermor Ltd | 2023-03-31 |
| 00810041989499 | Vive | VIVE HEALTH LLC | 2023-02-27 |
| 00810113570327 | CoreTech | VIVE HEALTH LLC | 2023-02-27 |
| 00810113572376 | Vive | VIVE HEALTH LLC | 2023-02-27 |
| 00810041986191 | CoreTech | VIVE HEALTH LLC | 2022-07-15 |
| 00810041986207 | CoreTech | VIVE HEALTH LLC | 2022-07-15 |
| 00636257010815 | MEDI | MEDI MANUFACTURING, INC. | 2020-06-18 |
| 00049022997875 | Walgreens | WALGREEN CO. | 2020-05-18 |
| 00049022997882 | Walgreens | WALGREEN CO. | 2020-05-10 |
| 00049022754973 | Walgreens | WALGREEN CO. | 2020-05-09 |
| 50311917171291 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |