About This 510(k) Submission
K213116 is an FDA 510(k) clearance for the Everyway Incontinence Stimulation System, a Stimulator, Electrical, Non-implantable, For Incontinence (Class II — Special Controls, product code KPI), submitted by Everyway Medical Instruments Co.,Ltd (Shenkeng District, New Taipei City, CN). The FDA issued a Cleared decision on December 3, 2021, 67 days after receiving the submission on September 27, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5320.