510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QJQClass II

Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

21 CFR 882.5800 / Neurology
FDA source (opens on fda.gov)

QJQ is the FDA product code for Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety, a class II device type, regulated under 21 CFR 882.5800. FDA's definition for this code reads: "To provide electrical current to the head to treat insomnia and/or anxiety". As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QJQ
Device name
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
FDA definition
To provide electrical current to the head to treat insomnia and/or anxiety
Regulation
21 CFR 882.5800
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
19
Ingested recalls
1

Clearances, product code QJQ

By decision year
19 clearances under product code QJQ with a decision year between 1977 and 2025, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QJQ by decision year
YearClearances
19771
19871
19881
19892
19902
19922
19951
20031
20061
20071
20081
20091
20191
20231
20241
20251

Applicants with the most clearances

Product code QJQ
Applicants holding the most 510(k) clearances under product code QJQ
ApplicantClearances
Medical Consultants Intl., Ltd.2
Neurovalens2
Auri-Stem Medical, Inc.1
Biorest, Inc.1
Biotronics Corp.1
Electromedical Products, Inc.1
Healthdirections, Inc.1
Innovative Neurological Devices, LLC1
Johari Digital Healthcare, Ltd.1
Kalaco Scientific, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order