The following data is part of a premarket notification filed by Pollogen, Ltd with the FDA for Legend Pro Dma.
| Device ID | K200545 |
| 510k Number | K200545 |
| Device Name: | Legend Pro DMA |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Pollogen, Ltd 6 Kaufman Street Tel Aviv, IL 6801298 |
| Contact | Ayala Kamil |
| Correspondent | Amaya De Levie Benjamin L. England And Associates 810 Landmark Dr, Suite 126 Glen Burnie, MD 21061 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-03 |
| Decision Date | 2021-10-21 |