The following data is part of a premarket notification filed by Dm Systems, Incorporated with the FDA for Heelsafe Dvt Hose, Models 00800-00804, 00805-00809.
| Device ID | K101614 |
| 510k Number | K101614 |
| Device Name: | HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | DM SYSTEMS, INCORPORATED 1105 BUCHBRUSH DR Folsm, CA 95630 |
| Contact | Michael Zmuda |
| Correspondent | Michael Zmuda DM SYSTEMS, INCORPORATED 1105 BUCHBRUSH DR Folsm, CA 95630 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-09 |
| Decision Date | 2011-01-13 |