DeviceClearance

Product code QBC— Neurology

Cala kIQ

Classification name
External Upper Limb Tremor Stimulator
Device class
Class 2
Regulation
21 CFR 882.5897
Advisory panel
Neurology
Total cleared
9
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QBC under 21 CFR 882.5897, via openFDA

Market context for product code QBC

FDA has cleared 9 devices under product code QBC between 2018 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QBC

Recent clearances under product code QBC

Data sourced from openFDA. This site is unofficial and independent of the FDA.