The following data is part of a premarket notification filed by Department Of Medical Physics And Biomedical Eng. with the FDA for The Odfs Dropped Foot Stimulator.
| Device ID | K050991 |
| 510k Number | K050991 |
| Device Name: | THE ODFS DROPPED FOOT STIMULATOR |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG. ONE CHAGRIN HIGHLANDS 2000 AUBURN DRIVE, SUITE 320 Cleveland, OH 44122 |
| Contact | Tina Lechman |
| Correspondent | Tina Lechman DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG. ONE CHAGRIN HIGHLANDS 2000 AUBURN DRIVE, SUITE 320 Cleveland, OH 44122 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-19 |
| Decision Date | 2005-07-15 |
| Summary: | summary |