Product code JXK
- Device name
- Cranial Electrotherapy Stimulator To Treat Depression
- Medical specialty
- Neurology
- Device class
- 3
- Regulation number
- 882.5800
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P230024S001 | Flow FL-100 | Flow Neuroscience AB | 2026-07-14 |
| P250010 | Proliv™Rx System | Neurolief , Ltd. | 2025-12-31 |
| P230024 | Flow FL-100 | Flow Neuroscience AB | 2025-12-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 17314585010010 | Flow Neuroscience | Flow Neuroscience AB | 2026-07-24 |
| 17314581000107 | Flow Neuroscience | Flow Neuroscience AB | 2026-07-24 |
| 17314585010003 | Flow Neuroscience | Flow Neuroscience AB | 2026-07-02 |
| 07314581000001 | Flow Neuroscience | Flow Neuroscience AB | 2026-06-24 |
| 00857869005277 | Alpha-Stim Conducting Solution | Electromedical Products International, Inc. | 2021-11-30 |
| 00857869005284 | Alpha-Stim Conducting Solution | Electromedical Products International, Inc. | 2021-11-30 |
| 08908008085406 | Johari Digital Healthcare Ltd. | SYRMA JOHARI MEDTECH LIMITED | 2021-03-12 |
| B788KS02001 | Nexalin | NEXALIN TECHNOLOGY | 2019-10-07 |
| B788KS02000 | Nexalin | NEXALIN TECHNOLOGY | 2019-10-01 |
| 00860001493306 | Cervella | INNOVATIVE NEUROLOGICAL DEVICES LLC | 2019-04-30 |
| 08908008085314 | Johari Digital Healthcare Ltd. | SYRMA JOHARI MEDTECH LIMITED | 2019-04-30 |
| 08908008085321 | 7E Wellness | SYRMA JOHARI MEDTECH LIMITED | 2019-04-30 |
| M750AR635A0 | CES-Ultra | NEURO-FITNESS LLC | 2017-06-30 |
| M750AR635A | CES-Ultra | NEURO-FITNESS LLC | 2017-02-12 |
| 00857869005239 | TruDenta Earclip Electrode Pad | Electromedical Products International, Inc. | 2015-06-30 |
| 00857869005161 | Alpha-Stim Earclip Electrode (M) | Electromedical Products International, Inc. | 2014-08-29 |
| 00857869005178 | Alpha-Stim Earclip Electrode (AID) | Electromedical Products International, Inc. | 2014-08-29 |
| 00857869005079 | Alpha Conducting Solution | Electromedical Products International, Inc. | 2014-08-25 |
| 00857869005031 | Alpha-Stim Earclip Electrode Pad | Electromedical Products International, Inc. | 2014-08-25 |
| 00857869005086 | Alpha Conducting Solution | Electromedical Products International, Inc. | 2014-08-25 |
| 00857869005093 | Alpha-Stim Earclip Electrode (CE3) | Electromedical Products International, Inc. | 2014-08-25 |
| 00857869005130 | Alpha-Stim Earclip Electrode (AID) | Electromedical Products International, Inc. | 2014-08-25 |