Cleared Abbreviated

INWAVE

K121820 · Zynex Medical, Inc. · Gastroenterology & Urology
Aug 2012
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K121820 is an FDA 510(k) clearance for the INWAVE, a Stimulator, Electrical, Non-implantable, For Incontinence (Class II — Special Controls, product code KPI), submitted by Zynex Medical, Inc. (Lone Tree, US). The FDA issued a Cleared decision on August 24, 2012, 64 days after receiving the submission on June 21, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5320.

Submission Details

510(k) Number K121820 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2012
Decision Date August 24, 2012
Days to Decision 64 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KPI — Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5320

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