BT-1000
FDA 510(k) K232991 · Bistos Co., Ltd.
510(k) numberK232991
Submission
- Device name
- BT-1000
- Applicant
- Bistos Co., Ltd.
Gyeonggi, KR - Received
- September 22, 2023
- Decision date
- August 28, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QGL – Transcutaneous Nerve Stimulator For Adhd
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5898
- Specialty
- Neurology
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.
Other 510(k)s with product code QGL
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Questions and answers
When was BT-1000 cleared by the FDA?
BT-1000 (K232991) received a 510(k) decision of Substantially Equivalent on August 28, 2024, 341 days after the submission was received.
What is the product code of K232991?
The FDA product code is QGL – Transcutaneous Nerve Stimulator For Adhd, a Class II (moderate risk) device regulated under 21 CFR 882.5898.