510(k) K250096
K250096 is an FDA 510(k) premarket notification submitted by Fasikl Incorporated for the device "Felix NeuroAI System". The FDA issued a decision of Substantially Equivalent on Jul 1, 2025. The device falls under product code QBC (External Upper Limb Tremor Stimulator), a Class II device regulated under 21 CFR 882.5897.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 1, 2025
- Date Received
- Jan 14, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Upper Limb Tremor Stimulator
- Device Class
- Class II
- Regulation Number
- 882.5897
- Review Panel
- NE
- Submission Type
An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.