Cleared Traditional

Drug Relief

K173861 · Dyansys, Inc. · Neurology
May 2018
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K173861 is an FDA 510(k) clearance for the Drug Relief, a Percutaneous Nerve Stimulator For Opioid Withdrawal (Class II — Special Controls, product code PZR), submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on May 2, 2018, 133 days after receiving the submission on December 20, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5896.

Submission Details

510(k) Number K173861 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2017
Decision Date May 02, 2018
Days to Decision 133 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code PZR — Percutaneous Nerve Stimulator For Opioid Withdrawal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5896
Definition Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders.