The following data is part of a premarket notification filed by Sport-elec S.a. with the FDA for Body Control System Family, Body Control Duo And Ct5.
| Device ID | K081026 |
| 510k Number | K081026 |
| Device Name: | BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | SPORT-ELEC S.A. 144 RESEARCH DRIVE Hampton, VA 23666 |
| Contact | Sharon Scannell |
| Correspondent | Sharon Scannell SPORT-ELEC S.A. 144 RESEARCH DRIVE Hampton, VA 23666 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-10 |
| Decision Date | 2008-11-05 |
| Summary: | summary |