The following data is part of a premarket notification filed by Medical Currents Ltd with the FDA for Bionicgym Powered Muscle Stimulator.
| Device ID | K182794 |
| 510k Number | K182794 |
| Device Name: | BionicGym Powered Muscle Stimulator |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Medical Currents Ltd 8 Cuffe Lane Dublin 2, IE D02w840 |
| Contact | Louis Crowe |
| Correspondent | Roger Gray Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, IT 00153 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-01 |
| Decision Date | 2019-07-18 |