FDA Product Code QPL: Electromagnetic Stimulator, Pain Relief
Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain.
Leading manufacturers include Tonica Elektronik A/S, Neuralace Medical, Inc. and Fotona D.O.O..
FDA 510(k) Cleared Electromagnetic Stimulator, Pain Relief Devices (Product Code QPL)
About Product Code QPL - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code QPL since 2021, with 6 receiving FDA clearance (average review time: 185 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QPL have taken an average of 206 days to reach a decision - up from 164 days historically. Manufacturers should account for longer review timelines in current project planning.
QPL devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →