Cleared Traditional

BT-1000

K232991 · Bistos Co., Ltd. · Neurology
Aug 2024
Decision
341d
Days
Class 2
Risk

About This 510(k) Submission

K232991 is an FDA 510(k) clearance for the BT-1000, a Transcutaneous Nerve Stimulator For Adhd (Class II — Special Controls, product code QGL), submitted by Bistos Co., Ltd. (Gyeonggi, KR). The FDA issued a Cleared decision on August 28, 2024, 341 days after receiving the submission on September 22, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5898.

Submission Details

510(k) Number K232991 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2023
Decision Date August 28, 2024
Days to Decision 341 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code QGL — Transcutaneous Nerve Stimulator For Adhd
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5898
Definition A Transcutaneous Electrical Nerve Stimulator For Attention Deficit Hyperactivity Disorder (adhd) Is A Prescription Device That Stimulates Transcutaneously Or Percutaneously Through Electrodes Placed On The Forehead.