The following data is part of a premarket notification filed by Compex Technologies, Inc. with the FDA for Rehabilicare If 3 Wave Interferential Stimulator System, Model 7110s.
| Device ID | K050046 |
| 510k Number | K050046 |
| Device Name: | REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S |
| Classification | Stimulator, Muscle, Powered |
| Applicant | COMPEX TECHNOLOGIES, INC. 1811 OLD HIGHWAY 8 New Brighton, MN 55112 |
| Contact | Brian J Edwards |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-01-10 |
| Decision Date | 2005-04-13 |
| Summary: | summary |