K941926 is an FDA 510(k) clearance for the MEDI STRUMPF. 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 Medi USA, LP (Arlington Heights, US). The FDA issued a Cleared decision on June 15, 1994, 56 days after receiving the submission on April 20, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5780.
| 510(k) Number | K941926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 1994 |
| Decision Date | June 15, 1994 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| 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 |