Product code KNP
- Device name
- Orthosis, Corrective Shoe
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3475
- 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 |
|---|---|---|---|
| K831690 | IPOS ANTI-ADDUCTUS SHOE | Ipos Luneburg | 1983-06-24 |
| K831552 | SORBOTHANE VISCO INNER SOLE PAD | Fred Sammons, Inc. | 1983-06-08 |
| K823654 | SLIP-ON SANDALS FOR MEASURING SHORTNESS | Fred Sammons, Inc. | 1983-01-21 |
| K823665 | ROTATION BOOT | Warm & Form, Orthopedic Materials | 1982-12-30 |
| K810228 | SORBOTHANE | Hamilton Kent | 1981-02-10 |
| K801743 | PLASTAZOTE SHOE | Alimed, Inc. | 1980-08-07 |
| K790326 | DRUSHOE | J.E. Hanger & Co. , Ltd. | 1979-02-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00609271000384 | KERRAPED PLUS™ All Purpose Boot | Darco (Europe) GmbH | 2023-02-13 |
| 00609271000377 | KERRAPED PLUS™ All Purpose Boot | Darco (Europe) GmbH | 2023-02-13 |
| 00609271000360 | KERRAPED PLUS™ All Purpose Boot | Darco (Europe) GmbH | 2023-02-13 |
| 00609271000353 | KERRAPED PLUS™ All Purpose Boot | Darco (Europe) GmbH | 2023-02-13 |
| 00609271001008 | Health Design EZY Close Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271000957 | Health Design Classic Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271000964 | Health Design Classic Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271000971 | Health Design Classic Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271000988 | Health Design Classic Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271000926 | Health Design Classic Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271001015 | Health Design EZY Close Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271001022 | Health Design EZY Close Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271001039 | Health Design EZY Close Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271001046 | Health Design EZY Close Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271001053 | Health Design EZY Close Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271001060 | Health Design EZY Close Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271001077 | Health Design EZY Close Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271000940 | Health Design Classic Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271000933 | Health Design Classic Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271000155 | DARCO® Commodus Open | Darco (Europe) GmbH | 2023-02-08 |
| 00609271000919 | Health Design Classic Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271000902 | Health Design Classic Post Op Shoe | DARCO INTERNATIONAL, INC. | 2023-02-08 |
| 00609271000285 | KERRAPED™ All Purpose Boot | Darco (Europe) GmbH | 2023-02-08 |
| 00609271000278 | KERRAPED™ All Purpose Boot | Darco (Europe) GmbH | 2023-02-08 |
| 00609271000261 | KERRAPED™ All Purpose Boot | Darco (Europe) GmbH | 2023-02-08 |
| 00609271000254 | KERRAPED™ All Purpose Boot | Darco (Europe) GmbH | 2023-02-08 |
| 00609271000193 | DARCO® Commodus Open | Darco (Europe) GmbH | 2023-02-08 |
| 00609271000186 | DARCO® Commodus Open | Darco (Europe) GmbH | 2023-02-08 |
| 00609271000179 | DARCO® Commodus Open | Darco (Europe) GmbH | 2023-02-08 |
| 00609271000162 | DARCO® Commodus Open | Darco (Europe) GmbH | 2023-02-08 |