QJQ — Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety Class II
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 |