Device, Finger-Sucking
The Finger-Sucking Device is a dental or behavioral device placed in the mouth or on the finger to discourage thumb or finger sucking habits in children, typically by providing a physical barrier or an aversive stimulus. It is classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LQX, regulated under 21 CFR 890.3475, within the Physical Medicine specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under the Quality System regulation.
Research product code LQX in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- LQX
- Device Class
- FDA class 1
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.