510(k) K232991
K232991 is an FDA 510(k) premarket notification submitted by Bistos Co., Ltd. for the device "BT-1000". The FDA issued a decision of Substantially Equivalent on August 28, 2024. The device falls under product code QGL (Transcutaneous Nerve Stimulator For Adhd), a Class II device regulated under 21 CFR 882.5898. Bistos Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2024
- Date Received
- September 22, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcutaneous Nerve Stimulator For Adhd
- Device Class
- Class II
- Regulation Number
- 882.5898
- Review Panel
- NE
- Submission Type
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.