Product code ISH
- Device name
- Component, External, Limb, Ankle/Foot
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3420
- 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 |
|---|---|---|---|
| K051256 | SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC | Noble Fiber Technologies, Inc. | 2005-07-21 |
| K823396 | FREE FLEX HEEL HEIGHT ADJUSTOR | Orthopedic Systems, Inc. | 1982-11-29 |
| K820505 | ANKLE/FOOT EXTERNAL | Mauch Laboratories, Inc. | 1982-03-08 |
| K791331 | THE TUCKER-SACH FOOT AND TUCKER-SYME FT | Kiswood Manufacturing, Inc. | 1979-08-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195411109517 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109654 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109647 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109630 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109623 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109616 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109609 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109593 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109586 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109579 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109562 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109555 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109548 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109531 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109524 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109364 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109500 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109494 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109487 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109470 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109463 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109456 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109449 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109432 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109425 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109418 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109401 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109395 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109388 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |
| 00195411109371 | Accent | COLLEGE PARK INDUSTRIES, INC. | 2023-09-12 |