| Device Type ID | 5136 |
| Device Name | Shoe, Cast |
| Regulation Description | Prosthetic And Orthotic Accessory. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.3025 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IPG |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5136 |
| Device | Shoe, Cast |
| Product Code | IPG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Prosthetic And Orthotic Accessory. |
| CFR Regulation Number | 890.3025 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Component Missing | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
Pocket Stimulation | 1 |
Bent | 1 |
Communication Or Transmission Problem | 1 |
Incorrect Device Or Component Shipped | 1 |
Naturally Worn | 1 |
| Total Device Problems | 12 |