The following data is part of a premarket notification filed by Sport-elec with the FDA for Sport-elec Body Control System.
| Device ID | K091865 |
| 510k Number | K091865 |
| Device Name: | SPORT-ELEC BODY CONTROL SYSTEM |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | SPORT-ELEC 141 RESEARCH DRIVE COMPLIANCE DEPT. Hampton, VA 23666 |
| Contact | Kimberly Jones |
| Correspondent | Kimberly Jones SPORT-ELEC 141 RESEARCH DRIVE COMPLIANCE DEPT. 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 | 2009-06-19 |
| Decision Date | 2009-11-13 |
| Summary: | summary |