QJQ
19 FDA 510(k) clearances · Product code
202 daysmedian time to decision
672 days90th percentile
19clearances measured
FDA profile
- Official device name
- Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5800
- Medical specialty
- Neurology
- FDA definition
- To provide electrical current to the head to treat insomnia and/or anxiety
- Adverse events (MAUDE)
- 2023: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Genesis Sleep (K252951) | Neurofield, Inc. | 2025-12-31 |
| Modius Stress (K232253) | Neurovalens Limited | 2024-03-27 |
| Modius Sleep (K230826) | Neurovalens , Ltd. | 2023-10-27 |
| Cervella (K182311) | Innovative Neurological Devices, LLC | 2019-03-07 |
| CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C (K090052) | Johari Digital Healthcare , Ltd. | 2009-05-29 |
| ELEXOMA MEDIC (K070412) | Redplane AG | 2008-05-21 |
| CES ULTRA (K062284) | Neuro-Fitness, LLC | 2007-04-05 |
| NET-2000 MICROCURRENT STIMULATOR (K060158) | Auri-Stem Medical, Inc. | 2006-10-13 |
| TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 (K024377) | Kalaco Scientific, Inc. | 2003-07-21 |
| NH-2002 (K932050) | New Horizon Health Care | 1995-06-05 |
| ALPHA-STIM CS (K903014) | Electromedical Products, Inc. | 1992-05-12 |
| LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR (K910616) | Life Balance Intl., Inc. | 1992-05-12 |
| LISS CRANIAL STIMULATOR MODEL SBL202-B (K903654) | Medical Consultants Intl. , Ltd. | 1990-10-04 |
| LISS CRANIAL STIMULATOR MODEL SBL201-M (K894515) | Medical Consultants Intl. , Ltd. | 1990-05-03 |
| NF-1 MINDPEACE (K895175) | Neurofitness | 1989-11-08 |
| NTI-1000 (K894097) | Neurotek, Inc. | 1989-09-25 |
| HP-1 (HEALTHPAX) (K883812) | Healthdirections, Inc. | 1988-11-28 |
| BR-2 BIOREST (K873920) | Biorest, Inc. | 1987-12-29 |
| BIOTRON 18 (K771534) | Biotronics Corp. | 1977-08-26 |
Track QJQ automatically
Every clearance here is in the API, with alerts when new ones post.