K123398 is an FDA 510(k) clearance for the DR. SCHOLL'S COMPRESSION SOCKS. This device is classified as a Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (Class II - Special Controls, product code DWL).
Submitted by Renfro Corporation (Mount Airy, US). The FDA issued a Cleared decision on December 18, 2012, 43 days after receiving the submission on November 5, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5780.
| 510(k) Number | K123398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2012 |
| Decision Date | December 18, 2012 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | DWL — Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5780 |