510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232991Substantially Equivalent

Bt-1000

Bistos co., Ltd., Gyeonggi, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232991 is the FDA 510(k) clearance record for BT-1000, a class II device, cleared for Bistos Co., Ltd. on under FDA product code QGL (Transcutaneous Nerve Stimulator For Adhd). FDA's definition for product code QGL reads: "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". FDA records list 11 510(k) clearances for Bistos Co., Ltd., from to . As of , FDA records show no recalls naming K232991.

Clearance record

Decision date
Received
(341 days to decision)
Product code
QGL Transcutaneous Nerve Stimulator For Adhd
Regulation
21 CFR 882.5898
Device class
Class II
Review panel
Neurology
Applicant
Bistos Co., Ltd. 7th Floor , A Bldg., Woolim Lions Valley 5-Cha, 302, Gyeonggi, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QGL

Trailing 12 months

FDA records hold no clearances under product code QGL in the trailing twelve months.

FDA records show no clearances under product code QGL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QGL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260