QJQ — Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety Class II
FDA product code QJQ covers "Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety", a Class II medical device regulated under 21 CFR 882.5800. Submissions are reviewed by the Neurology panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QJQ
- Device Class
- Class II
- Regulation Number
- 882.5800
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
To provide electrical current to the head to treat insomnia and/or anxiety
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252951 | neurofield | Genesis Sleep | December 31, 2025 |
| K232253 | neurovalens limited | Modius Stress | March 27, 2024 |
| K230826 | neurovalens | Modius Sleep | October 27, 2023 |
| K182311 | innovative neurological devices | Cervella | March 7, 2019 |
| K090052 | johari digital healthcare | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C | May 29, 2009 |
| K070412 | redplane | ELEXOMA MEDIC | May 21, 2008 |
| K062284 | neuro-fitness | CES ULTRA | April 5, 2007 |
| K060158 | auri-stem medical | NET-2000 MICROCURRENT STIMULATOR | October 13, 2006 |
| K024377 | kalaco scientific | TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 | July 21, 2003 |
| K932050 | new horizon health care | NH-2002 | June 5, 1995 |
| K903014 | electromedical products | ALPHA-STIM CS | May 12, 1992 |
| K910616 | life balance intl | LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR | May 12, 1992 |
| K903654 | medical consultants intl. | LISS CRANIAL STIMULATOR MODEL SBL202-B | October 4, 1990 |
| K894515 | medical consultants intl. | LISS CRANIAL STIMULATOR MODEL SBL201-M | May 3, 1990 |
| K895175 | neurofitness | NF-1 MINDPEACE | November 8, 1989 |
| K894097 | neurotek | NTI-1000 | September 25, 1989 |
| K883812 | healthdirections | HP-1 (HEALTHPAX) | November 28, 1988 |
| K873920 | biorest | BR-2 BIOREST | December 29, 1987 |
| K771534 | biotronics | BIOTRON 18 | August 26, 1977 |