The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Slendertone Flex Abdominal Training System, Type 515.
| Device ID | K030708 |
| 510k Number | K030708 |
| Device Name: | SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, West Galway, IE |
| Contact | Michelle Sawyer |
| Correspondent | Michelle Sawyer BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, West Galway, IE |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-06 |
| Decision Date | 2003-06-25 |
| Summary: | summary |