Product code IPX
- Device name
- Orthosis, Rib Fracture, 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00190446660576 | PROCARE | DJO, LLC | 2025-07-23 |
| 04823097723708 | "TM ""Rehabilitimed"" BR-1 XL Comfort" | REABILITIMED TOV | 2025-06-19 |
| 04823097723685 | "TM ""Rehabilitimed"" BR-1 M Comfort" | REABILITIMED TOV | 2025-06-19 |
| 04823097723678 | "TM ""Rehabilitimed"" BR-1 S Comfort" | REABILITIMED TOV | 2025-06-19 |
| 04823097721698 | "TM ""Rehabilitimed"" BR-2 XXL Comfort" | REABILITIMED TOV | 2025-06-19 |
| 04823097721681 | "TM ""Rehabilitimed"" BR-2 XL Comfort" | REABILITIMED TOV | 2025-06-19 |
| 04823097721674 | "TM ""Rehabilitimed"" BR-2 L Comfort" | REABILITIMED TOV | 2025-06-19 |
| 04823097721667 | "TM ""Rehabilitimed"" BR-2 M Comfort" | REABILITIMED TOV | 2025-06-19 |
| 04823097721650 | "TM ""Rehabilitimed"" BR-2 S Comfort" | REABILITIMED TOV | 2025-06-19 |
| 04823097723692 | "TM ""Rehabilitimed"" BR-1 L Comfort" | REABILITIMED TOV | 2025-06-19 |
| 04823097723715 | "TM ""Rehabilitimed"" BR-1 XXL Comfort" | REABILITIMED TOV | 2025-06-19 |
| 04823097706954 | "TM ""Rehabilitimed"" BR-2 M" | REABILITIMED TOV | 2025-05-04 |
| 04823097706886 | "TM ""Rehabilitimed"" BR-2 S" | REABILITIMED TOV | 2025-05-04 |
| 04823097706893 | "TM ""Rehabilitimed"" BR-2 M" | REABILITIMED TOV | 2025-05-04 |
| 04823097706909 | "TM ""Rehabilitimed"" BR-2 L" | REABILITIMED TOV | 2025-05-04 |
| 04823097706916 | "TM ""Rehabilitimed"" BR-2 XL" | REABILITIMED TOV | 2025-05-04 |
| 04823097706923 | "TM ""Rehabilitimed"" BR-2 XXL" | REABILITIMED TOV | 2025-05-04 |
| 04823097706930 | "TM ""Rehabilitimed"" BR-2 XXXL" | REABILITIMED TOV | 2025-05-04 |
| 04823097706947 | "TM ""Rehabilitimed"" BR-2 S" | REABILITIMED TOV | 2025-05-04 |
| 00609271952607 | MECRON Torso Sonderanfertigung | Darco (Europe) GmbH | 2023-02-14 |
| 00609271951426 | MECRON Torso MaBanfertigung | Darco (Europe) GmbH | 2023-02-14 |
| 00609271951402 | MECRON Thorax Women B: 14,5 cm, U: 72-98 cm | Darco (Europe) GmbH | 2023-02-14 |
| 00609271950177 | MECRON Belt B: 29 cm, U: 130-157 cm | Darco (Europe) GmbH | 2023-02-14 |
| 00609271950160 | MECRON Belt B: 29 cm, U: 105-127 cm | Darco (Europe) GmbH | 2023-02-14 |
| 00609271950153 | MECRON Belt B: 29 cm, U: 84-110 cm | Darco (Europe) GmbH | 2023-02-14 |
| 00609271950146 | MECRON Belt B: 29 cm, U: 66-86 cm | Darco (Europe) GmbH | 2023-02-14 |
| 00609271950139 | MECRON Belt B: 22 cm, U: 130-157 cm | Darco (Europe) GmbH | 2023-02-14 |
| 00609271950122 | MECRON Belt B: 22 cm, U: 105-127 cm | Darco (Europe) GmbH | 2023-02-14 |
| 00609271950115 | MECRON Belt B: 22 cm, U: 84-110 cm | Darco (Europe) GmbH | 2023-02-14 |
| 00609271950108 | MECRON Belt B: 22 cm, U: 66-86 cm | Darco (Europe) GmbH | 2023-02-14 |