FDA Product Code QBC: External Upper Limb Tremor Stimulator
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.
Leading manufacturers include Cala Health, Inc., Fasikl Incorporated and Encora, Inc..
FDA 510(k) Cleared External Upper Limb Tremor Stimulator Devices (Product Code QBC)
About Product Code QBC - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code QBC since 2018, with 8 receiving FDA clearance (average review time: 169 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QBC have taken an average of 140 days to reach a decision - down from 205 days historically, suggesting improved FDA processing for this classification.
QBC devices are reviewed by the Neurology panel. Browse all Neurology devices →