Quell received FDA 510(k) Clearance in 2015 (K152954). FDA Clearance means that the FDA has deemed the device to be as safe and effective as a medical device previously cleared by the FDA; this is called “substantially equivalent.” This process is different from FDA approval of drugs and typically does not involve a review and analysis of clinical data. All transcutaneous electrical nerve stimulators (TENS) must be FDA cleared before they are marketed. The FDA 510(k) clearance for Quell specifically states that it may be used during sleep.
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