You read the title correctly, you need a prescription to get the device and the home page states it will be available this summer. There’s a lot of research and science here and I don’t know if we would consider it a DME article or something else? In case you are interested, it is made in the USA and comes with a warranty and is as easy to use as an electric toothbrush, according to the website. 
If one is recovering from a surgical procedure it serves as a therapy device and I guess otherwise it’s use as you want. The website is done professionally and has a long video to tell you all about it and the science behind the design. Until they are growing the organs you this or prescription pills as options and Wake Forest is working on the harvesting side of things. There’s also Horny Goat weed out there too with clinical trials for the food supplement side ED. BD
Regenerative Medicine News – Fully Functional Rabbit Penis Created That Works
Reflexonic LLC landed FDA clearance for the first hand-held, non-pharmaceutical device intended to help men with moderate erectile dysfunction, poor maintenance and rigidity or spinal cord injuries achieve successful erection and ejaculation at home.
Viberect is the only device in the world that delivers targeted vibration applied to the top and bottom of the penis using medical pads that stimulate the pudendal and dorsal nerves.
Reflexonic called on Texas-based medical device consultancy firm Emergo Group to aid it through the regulatory bid, and the companies spent two months writing the 510(k) application, which was submitted in February, according to the press release.
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