Product code KYS
- Device name
- Insoles, Medical
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6280
- Review panel
- HO
- 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#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K780719 | FUNGUS FIGHTER INSOLES | Combe, Inc. | 1978-10-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810179882273 | Copperfit | Ideavillage Products Corp | 2026-10-01 |
| 00810179882280 | Copperfit | Ideavillage Products Corp | 2026-10-01 |
| 00810179882297 | Copperfit | Ideavillage Products Corp | 2026-10-01 |
| 00810179882266 | Copperfit | Ideavillage Products Corp | 2026-10-01 |
| 00810041987792 | ViveSole | VIVE HEALTH LLC | 2024-07-05 |
| 00810041987785 | ViveSole | VIVE HEALTH LLC | 2024-07-05 |
| 00810041987778 | ViveSole | VIVE HEALTH LLC | 2024-07-05 |
| 00041298994206 | Steins | D-M-S HOLDINGS, INC. | 2024-05-17 |
| 00041298994213 | Steins | D-M-S HOLDINGS, INC. | 2024-05-17 |
| 00041298994220 | Steins | D-M-S HOLDINGS, INC. | 2024-05-17 |
| 00810041989116 | Vivesole | VIVE HEALTH LLC | 2024-04-24 |
| 00810041989123 | Vivesole | VIVE HEALTH LLC | 2024-04-24 |
| 00041298994046 | Steins | D-M-S HOLDINGS, INC. | 2024-02-02 |
| 00041298994039 | Steins | D-M-S HOLDINGS, INC. | 2024-02-02 |
| 00041298993865 | Steins | D-M-S HOLDINGS, INC. | 2024-02-02 |
| 00041298994053 | Steins | D-M-S HOLDINGS, INC. | 2024-02-02 |
| 00810041988928 | ViveSole | VIVE HEALTH LLC | 2023-03-01 |
| 00810041989406 | ViveSole | VIVE HEALTH LLC | 2023-03-01 |
| 00810041989390 | ViveSole | VIVE HEALTH LLC | 2023-03-01 |
| 00810041989383 | ViveSole | VIVE HEALTH LLC | 2023-03-01 |
| 00810041989376 | ViveSole | VIVE HEALTH LLC | 2023-03-01 |
| 00810041989192 | ViveSole | VIVE HEALTH LLC | 2023-03-01 |
| 00810041988911 | ViveSole | VIVE HEALTH LLC | 2023-03-01 |
| 00810041988904 | ViveSole | VIVE HEALTH LLC | 2023-03-01 |
| 00810113571270 | ViveSole | VIVE HEALTH LLC | 2022-12-28 |
| 00810113571287 | ViveSole | VIVE HEALTH LLC | 2022-12-28 |
| 00810113571294 | ViveSole | VIVE HEALTH LLC | 2022-12-28 |
| 00810041983367 | ViveSole | VIVE HEALTH LLC | 2022-09-02 |
| 00810041983350 | ViveSole | VIVE HEALTH LLC | 2022-09-02 |
| 00810041988959 | Vivesole | VIVE HEALTH LLC | 2022-03-08 |