Rehabtronics Gets 510(k) Clearance for Neurostimulation Device
The FDA has granted 510(k) clearance to Rehabtronics’ Prelivia, a neurostimulation device that improves blood circulation and maintains healthy tissue in people who are bedridden or chairbound.
The newly cleared indication for Prelivia is the prevention of bed sores in such patients. The device offers an alternative to current preventive methods, such as turning patients or specialty beds and mattresses, which provide only temporary relief, the Vancouver, B.C.-based company said.
Prelivia’s patented neurostimulation technology increases tissue oxygenation by 28 percent and decreases pressure-induced tissue damage by 80 percent, the company said.