Cleared Special

Drug Relief v1

K221231 · Dyansys, Inc. · Neurology
Jun 2022
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K221231 is an FDA 510(k) clearance for the Drug Relief v1, 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 June 6, 2022, 38 days after receiving the submission on April 29, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5896.

Submission Details

510(k) Number K221231 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2022
Decision Date June 06, 2022
Days to Decision 38 days
Submission Type Special
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.