| Device Type ID | 2538 |
| Device Name | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| 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 | DWL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2538 |
| Device | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Product Code | DWL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Support Stocking. |
| CFR Regulation Number | 880.5780 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 3 |
Therapy Delivered To Incorrect Body Area | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Zimmer, Inc. | II | May-10-2014 |