FDA Product Code
FDA Product Code QJQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5800
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252951 | Genesis Sleep | Neurofield, Inc. | 2025-12-31 | Traditional | PDF ↗ |
| K232253 | Modius Stress | Neurovalens Limited | 2024-03-27 | Traditional | PDF ↗ |
| K230826 | Modius Sleep | Neurovalens , Ltd. | 2023-10-27 | Traditional | PDF ↗ |
| K182311 | Cervella | Innovative Neurological Devices, LLC | 2019-03-07 | Traditional | PDF ↗ |
| K090052 | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C | Johari Digital Healthcare , Ltd. | 2009-05-29 | Traditional | PDF ↗ |
| K070412 | ELEXOMA MEDIC | Redplane AG | 2008-05-21 | Traditional | PDF ↗ |
| K062284 | CES ULTRA | Neuro-Fitness, LLC | 2007-04-05 | Traditional | PDF ↗ |
| K060158 | NET-2000 MICROCURRENT STIMULATOR | Auri-Stem Medical, Inc. | 2006-10-13 | Traditional | PDF ↗ |
| K024377 | TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 | Kalaco Scientific, Inc. | 2003-07-21 | Traditional | PDF ↗ |
| K932050 | NH-2002 | New Horizon Health Care | 1995-06-05 | Traditional | PDF ↗ |
| K910616 | LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR | Life Balance Intl., Inc. | 1992-05-12 | Traditional | PDF ↗ |
| K903014 | ALPHA-STIM CS | Electromedical Products, Inc. | 1992-05-12 | Traditional | PDF ↗ |
| K903654 | LISS CRANIAL STIMULATOR MODEL SBL202-B | Medical Consultants Intl. , Ltd. | 1990-10-04 | Traditional | PDF ↗ |
| K894515 | LISS CRANIAL STIMULATOR MODEL SBL201-M | Medical Consultants Intl. , Ltd. | 1990-05-03 | Traditional | PDF ↗ |
| K895175 | NF-1 MINDPEACE | Neurofitness | 1989-11-08 | Traditional | PDF ↗ |
| K894097 | NTI-1000 | Neurotek, Inc. | 1989-09-25 | Traditional | PDF ↗ |
| K883812 | HP-1 (HEALTHPAX) | Healthdirections, Inc. | 1988-11-28 | Traditional | PDF ↗ |
| K873920 | BR-2 BIOREST | Biorest, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K771534 | BIOTRON 18 | Biotronics Corp. | 1977-08-26 | Traditional | PDF ↗ |
Product code QJQ · Class II · Neurology. Data: openFDA.