1 device · 1 company · 2025
Product code QBC: External Upper Limb Tremor Stimulator
1 device under product code QBC, 2025, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
External Upper Limb Tremor Stimulator. 21 CFR 882.5897, Class II. 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. MAUDE held 6 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Felix NeuroAI SystemK250096 · 510(k) | Fasikl Incorporated | Neurology | database entry |
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