Paindrainer AB´s digital tool is the first device targeting chronic pain to receive FDA registration approval as a Medical Device Class 1
MEDICON VILLAGE, LUND, SWEDEN – Paindrainer AB is pleased to announce that the company’s 360° patient-centric[©] app (Paindrainer® PD1) has received registration approval as a Medical Device Class 1 (510k exemption) by the U.S. Food and Drug Administration (FDA).A Medical Device Class 1 falls under the low risk category according to the FDA classification system, which was also in line with the absent of risk observed in the most recent multi-center trial in the US. "We are thrilled to share this significant achievement and milestone that the Paindrainer® App, as the first self-
