The following data is part of a premarket notification filed by Reliant Technologies, Inc. with the FDA for Reliant Btl 5000 Puls Electrical Stimulation System, Reliant Btl 5000 Sono Ultrasound System, Reliant Btl 5000 Combi.
| Device ID | K023050 |
| 510k Number | K023050 |
| Device Name: | RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | RELIANT TECHNOLOGIES, INC. P.O. BOX 405 Angels Camp, CA 95221 |
| Contact | Anne Worden |
| Correspondent | Anne Worden RELIANT TECHNOLOGIES, INC. P.O. BOX 405 Angels Camp, CA 95221 |
| Product Code | IMG |
| Subsequent Product Code | GXY |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IMI |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-13 |
| Decision Date | 2003-02-14 |
| Summary: | summary |