Product code IMP
- Device name
- Cushion, Wheelchair
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3920
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- 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 |
|---|---|---|---|
| 00848530080600 | Wheelchair Cushions | Sunset Healthcare Solutions, Inc. | 2024-08-06 |
| 00848530080617 | Wheelchair Cushions | Sunset Healthcare Solutions, Inc. | 2024-08-06 |
| 00848530080624 | Wheelchair Cushions | Sunset Healthcare Solutions, Inc. | 2024-08-06 |
| 00848530080631 | Wheelchair Cushions | Sunset Healthcare Solutions, Inc. | 2024-08-06 |
| 00848530080648 | Wheelchair Cushions | Sunset Healthcare Solutions, Inc. | 2024-08-06 |
| 00848530087241 | Wheelchair Cushions | Sunset Healthcare Solutions, Inc. | 2024-08-06 |
| 00848530080594 | Wheelchair Cushions | Sunset Healthcare Solutions, Inc. | 2024-08-06 |
| 00850013379279 | AXIOM | KI MOBILITY, LLC | 2023-05-08 |
| 00850013379286 | AXIOM | KI MOBILITY, LLC | 2023-05-08 |
| 00616784304212 | DMECare Solutions Solid Seat Insert | Dynarex Corporation | 2021-09-01 |
| 00616784304519 | DMECare Solutions Solid Seat Insert | Dynarex Corporation | 2021-09-01 |
| 00616784304410 | DMECare Solutions Solid Seat Insert | Dynarex Corporation | 2021-09-01 |
| 00616784304311 | DMECare Solutions Solid Seat Insert | Dynarex Corporation | 2021-09-01 |
| 00616784304113 | Dmecare Solutions Solid Seat Insert | Dynarex Corporation | 2021-09-01 |
| 00840117307605 | Ever-Soft Pommel Gel Foam Cushion 18" x 16" x 3" | Dynarex Corporation | 2021-04-22 |
| 00840117307629 | Ever-Soft Pommel Gel Foam Cushion 20" x 16" x 3" | Dynarex Corporation | 2021-04-22 |
| 00840117321113 | Bari+Max Bariatric Gel/Foam Cushion 26"x20"x3" | Dynarex Corporation | 2021-04-22 |
| 00840117321106 | Bari+Max Bariatric Gel/Foam Cushion 24"x18"x3" | Dynarex Corporation | 2021-04-22 |
| 00840117321090 | Bari+Max Bariatric Gel/Foam Cushion 22"x18"x3" | Dynarex Corporation | 2021-04-22 |
| 00840117321052 | Bari+Max Bariatric Gel Foam Wheelchair Cushion 26"x20" "x3" | Dynarex Corporation | 2021-04-22 |
| 00840117321045 | Bari+Max Bariatric Gel Foam Wheelchair Cushion 24"x18"x3" | Dynarex Corporation | 2021-04-22 |
| 00840117321038 | Bari+Max Bariatric Gel Foam Wheelchair Cushion 22"x18"x3" | Dynarex Corporation | 2021-04-22 |
| 00840117307766 | Ever-Soft Positioning Wedge | Dynarex Corporation | 2021-04-22 |
| 00840117307742 | Ever-Soft Positioning Wedge | Dynarex Corporation | 2021-04-22 |
| 00840117307728 | Ever-Soft Positioning Wedge | Dynarex Corporation | 2021-04-22 |
| 00850013379149 | AXIOM G | KI MOBILITY, LLC | 2020-09-21 |
| 00850013379156 | AXIOM SPV | KI MOBILITY, LLC | 2020-09-21 |
| 00850013379187 | AXIOM S | KI MOBILITY, LLC | 2020-09-21 |
| 00850013379194 | AXIOM P | KI MOBILITY, LLC | 2020-09-21 |
| 00850013379200 | AXIOM SPF | KI MOBILITY, LLC | 2020-09-21 |