The following data is part of a premarket notification filed by Compex Technologies, Inc. with the FDA for Staodyn Max Preset, Model 4470.
| Device ID | K061516 |
| 510k Number | K061516 |
| Device Name: | STAODYN MAX PRESET, MODEL 4470 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | COMPEX TECHNOLOGIES, INC. 1811 OLD HIGHWAY 8 New Brighton, MN 55112 |
| Contact | Carl Beaurline |
| Correspondent | Carl Beaurline COMPEX TECHNOLOGIES, INC. 1811 OLD HIGHWAY 8 New Brighton, MN 55112 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-01 |
| Decision Date | 2007-02-06 |
| Summary: | summary |