The following data is part of a premarket notification filed by Bio-medical Research Ltd with the FDA for Slendertone Evolve Abs, Type 735.
| Device ID | K203513 |
| 510k Number | K203513 |
| Device Name: | SLENDERTONE Evolve Abs, Type 735 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-30 |
| Decision Date | 2021-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391546170018 | K203513 | 000 |