DeviceClearance

Product code QJQ— Neurology

ALPHA-STIM CS

Classification name
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Device class
Class 2
Regulation
21 CFR 882.5800
Advisory panel
Neurology
Total cleared
19
First cleared
Most recent

FDA classification definition

“To provide electrical current to the head to treat insomnia and/or anxiety”

— U.S. Food and Drug Administration, device classification record for product code QJQ under 21 CFR 882.5800, via openFDA

Market context for product code QJQ

FDA has cleared 19 devices under product code QJQ between 1977 and 2025, filed by 18 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

last 15 years

Top applicants under product code QJQ

Recent clearances under product code QJQ

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