The following data is part of a premarket notification filed by Bio-medical Research Ltd with the FDA for Slendertone Corefit Abs 8, Type 734.
| Device ID | K180688 |
| 510k Number | K180688 |
| Device Name: | SLENDERTONE CoreFit Abs 8, Type 734 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Bio-Medical Research Ltd Parkmore Business Park West Galway, IE H91 Nht7 |
| Contact | Eoin Keating |
| Correspondent | Eoin Keating Bio-Medical Research Ltd Parkmore Business Park West Galway, IE H91 Nht7 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-15 |
| Decision Date | 2018-10-25 |
| Summary: | summary |