Product code IPW
- Device name
- Orthosis, Sacroiliac, Soft
- 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#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K811176 | TIGGES SPINAL | The Tiggs Co. | 1981-05-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04823097717776 | "TM ""Rehabilitimed"" GR-3P XL Comfort" | REABILITIMED TOV | 2025-05-05 |
| 04823097719831 | "TM ""Rehabilitimed"" GR-3P XXL Comfort" | REABILITIMED TOV | 2025-05-05 |
| 04823097719824 | "TM ""Rehabilitimed"" GR-3P XL Comfort" | REABILITIMED TOV | 2025-05-05 |
| 04823097719817 | "TM ""Rehabilitimed"" GR-3P L Comfort" | REABILITIMED TOV | 2025-05-05 |
| 04823097719800 | "TM ""Rehabilitimed"" GR-3P M Comfort" | REABILITIMED TOV | 2025-05-05 |
| 04823097719794 | "TM ""Rehabilitimed"" GR-3P S Comfort" | REABILITIMED TOV | 2025-05-05 |
| 04823097717806 | "TM ""Rehabilitimed"" GR-3P S Comfort" | REABILITIMED TOV | 2025-05-05 |
| 04823097717790 | "TM ""Rehabilitimed"" GR-3P M Comfort" | REABILITIMED TOV | 2025-05-05 |
| 04823097717783 | "TM ""Rehabilitimed"" GR-3P L Comfort" | REABILITIMED TOV | 2025-05-05 |
| 04823097717769 | "TM ""Rehabilitimed"" GR-3P XXL Comfort" | REABILITIMED TOV | 2025-05-05 |
| B54180030080 | Pelvic Binder | FARETEC, INC. | 2024-02-28 |
| B54180030050 | Pelvic Binder | FARETEC, INC. | 2023-03-16 |
| B54180030040 | Pelvic Binder | FARETEC, INC. | 2023-03-15 |
| B54180030000 | Pelvic Binder | FARETEC, INC. | 2023-03-15 |
| B54180030010 | Pelvic Binder | FARETEC, INC. | 2023-03-15 |
| B54180030020 | Pelvic Binder | FARETEC, INC. | 2023-03-15 |
| B54180030030 | Pelvic Binder | FARETEC, INC. | 2023-03-15 |
| B54180030060 | Pelvic Binder | FARETEC, INC. | 2023-03-15 |
| B54180030070 | Pelvic Binder | FARETEC, INC. | 2023-03-15 |
| 10822045428611 | SAM Pelvic Sling II | SAM Medical Products | 2022-09-01 |
| 10822045428628 | SAM Pelvic Sling II | SAM Medical Products | 2022-09-01 |
| 10822045428635 | SAM Pelvic Sling II | SAM Medical Products | 2022-09-01 |
| 00822045428614 | SAM Pelvic Sling II | SAM Medical Products | 2022-09-01 |
| 10822045428642 | SAM Pelvic Sling II | SAM Medical Products | 2022-09-01 |
| 00822045428645 | SAM Pelvic Sling II | SAM Medical Products | 2022-09-01 |
| 00822045428638 | SAM Pelvic Sling II | SAM Medical Products | 2022-09-01 |
| 00822045428621 | SAM Pelvic Sling II | SAM Medical Products | 2022-09-01 |
| 04250105612912 | n.a. | VBM Medizintechnik GmbH | 2020-08-31 |
| 04250105623208 | n.a. | VBM Medizintechnik GmbH | 2020-08-26 |
| 04250105612905 | n.a. | VBM Medizintechnik GmbH | 2020-08-26 |