| Device Type ID | 2660 |
| Device Name | Legging, Compression, Non-inflatable |
| Regulation Description | Medical Support Stocking. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5780 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LLK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2660 |
| Device | Legging, Compression, Non-inflatable |
| Product Code | LLK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Support Stocking. |
| CFR Regulation Number | 880.5780 [🔎] |
| Device Problems | |
|---|---|
Improper Or Incorrect Procedure Or Method | 2 |
Human-Device Interface Problem | 2 |
Material Integrity Problem | 1 |
Volume Accuracy Problem | 1 |
Insufficient Flow Or Under Infusion | 1 |
Device Or Device Fragments Location Unknown | 1 |
| Total Device Problems | 8 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Customed, Inc | I | Dec-16-2014 |