Cleared Traditional

ANSiStim-PP

K220397 · Dyansys, Inc. · Neurology
May 2022
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K220397 is an FDA 510(k) clearance for the ANSiStim-PP, a Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (Class II — Special Controls, product code NHI), submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on May 12, 2022, 90 days after receiving the submission on February 11, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K220397 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2022
Decision Date May 12, 2022
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code NHI — Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890
Definition Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A Pens Uses Electrodes That Are Placed Percutaneously To Deliver Stimulation,