Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Regulation 882.5800
1510(k)s in 12 months (19 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in QJQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Medical Consultants Intl. , Ltd. | 2 | 0 |
| Neurovalens , Ltd. | 2 | 0 |
| Auri-Stem Medical, Inc. | 1 | 0 |
| Biorest, Inc. | 1 | 0 |
| Biotronics Corp. | 1 | 0 |
| Electromedical Products, Inc. | 1 | 0 |
| Fisher Wallace Laboratories Inc. | 0 | 1 |
| Healthdirections, Inc. | 1 | 0 |
| Innovative Neurological Devices, LLC | 1 | 0 |
| Johari Digital Healthcare , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 31, 2025 | K252951 | Genesis Sleep Neurofield, Inc. | QJQ |
| Mar 27, 2024 | K232253 | Modius Stress Neurovalens Limited, GB | QJQ |
| Oct 27, 2023 | K230826 | Modius Sleep Neurovalens , Ltd., GB | QJQ |
| Mar 7, 2019 | K182311 | Cervella Innovative Neurological Devices, LLC | QJQ |
| May 29, 2009 | K090052 | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C Johari Digital Healthcare , Ltd., IN | QJQ |
| May 21, 2008 | K070412 | ELEXOMA MEDIC Redplane AG, CH | QJQ |
| Apr 5, 2007 | K062284 | CES ULTRA Neuro-Fitness, LLC | QJQ |
| Oct 13, 2006 | K060158 | NET-2000 MICROCURRENT STIMULATOR Auri-Stem Medical, Inc. | QJQ |
| Jul 21, 2003 | K024377 | TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 Kalaco Scientific, Inc. | QJQ |
| Jun 5, 1995 | K932050 | NH-2002 New Horizon Health Care | QJQ |
| May 12, 1992 | K910616 | LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR Life Balance Intl., Inc. | QJQ |
| May 12, 1992 | K903014 | ALPHA-STIM CS Electromedical Products, Inc. | QJQ |
| Oct 4, 1990 | K903654 | LISS CRANIAL STIMULATOR MODEL SBL202-B Medical Consultants Intl. , Ltd. | QJQ |
| May 3, 1990 | K894515 | LISS CRANIAL STIMULATOR MODEL SBL201-M Medical Consultants Intl. , Ltd. | QJQ |
| Nov 8, 1989 | K895175 | NF-1 MINDPEACE Neurofitness | QJQ |
| Sep 25, 1989 | K894097 | NTI-1000 Neurotek, Inc. | QJQ |
| Nov 28, 1988 | K883812 | HP-1 (HEALTHPAX) Healthdirections, Inc. | QJQ |
| Dec 29, 1987 | K873920 | BR-2 BIOREST Biorest, Inc. | QJQ |
| Aug 26, 1977 | K771534 | BIOTRON 18 Biotronics Corp. | QJQ |
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