The following data is part of a premarket notification filed by Sport-elec S.a. with the FDA for Sport-elec, Models Duo Ct5 Slimness And Ct5 Slimness.
| Device ID | K061914 |
| 510k Number | K061914 |
| Device Name: | SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | SPORT-ELEC S.A. ROUTE DE POUEN BP 35 Bourgtheroulde Infreville, FR 91400 |
| Contact | Armelle Laprelle |
| Correspondent | Armelle Laprelle SPORT-ELEC S.A. ROUTE DE POUEN BP 35 Bourgtheroulde Infreville, FR 91400 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-06 |
| Decision Date | 2007-07-26 |
| Summary: | summary |