The following data is part of a premarket notification filed by Selective Med Components, Inc. with the FDA for Io-drive.
| Device ID | K993081 |
| 510k Number | K993081 |
| Device Name: | IO-DRIVE |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | SELECTIVE MED COMPONENTS, INC. 6 S. MECHANIC ST. Mount Vernon, OH 43050 |
| Contact | Rick Fisher |
| Correspondent | Rick Fisher SELECTIVE MED COMPONENTS, INC. 6 S. MECHANIC ST. Mount Vernon, OH 43050 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-15 |
| Decision Date | 2000-03-03 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IO-DRIVE 75865474 not registered Dead/Abandoned |
Selective Med Components 1999-12-20 |