CES-Ultra
- Primary DI
- M750AR635A
- Brand
- CES-Ultra
- Company
- NEURO-FITNESS LLC
- Model
- AR635A
- Catalog number
- CES-Ultra
- Device description
- Cranial Electrotherapy Stimulator
- Published
- 2017-02-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
Code, Name table| Code | Name |
|---|
| JXK | Stimulator, Cranial Electrotherapy |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| JXK | Cranial Electrotherapy Stimulator To Treat Depression | Neurology | 3 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| M750AR635A | Primary | HIBCC | 0 | |
Regulatory Flags#
- DUNS number
- 078513618
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
Primary DI, Brand, Model table| Primary DI | Brand | Model | Catalog | Published |
|---|
| M750AR636B0 | Calm Ultra | AR635A | Calm Ultra | 2026-07-29 |
| M750AR635A0 | CES-Ultra | AR635A | CES-Ultra | 2017-06-30 |
Other Devices Sharing Product Codes#
Primary DI, Brand, Company table| Primary DI | Brand | Company | Product code | Published |
|---|
| 17314581000107 | Flow Neuroscience | Flow Neuroscience AB | JXK | 2026-07-24 |
| 17314585010010 | Flow Neuroscience | Flow Neuroscience AB | JXK | 2026-07-24 |
| 17314585010003 | Flow Neuroscience | Flow Neuroscience AB | JXK | 2026-07-02 |
| 07314581000001 | Flow Neuroscience | Flow Neuroscience AB | JXK | 2026-06-24 |
| 00857869005277 | Alpha-Stim Conducting Solution | Electromedical Products International, Inc. | JXK | 2021-11-30 |
| 00857869005284 | Alpha-Stim Conducting Solution | Electromedical Products International, Inc. | JXK | 2021-11-30 |
| 08908008085406 | Johari Digital Healthcare Ltd. | SYRMA JOHARI MEDTECH LIMITED | JXK | 2021-03-12 |
| B788KS02001 | Nexalin | NEXALIN TECHNOLOGY | JXK | 2019-10-07 |
| B788KS02000 | Nexalin | NEXALIN TECHNOLOGY | JXK | 2019-10-01 |
| 00860001493306 | Cervella | INNOVATIVE NEUROLOGICAL DEVICES LLC | JXK | 2019-04-30 |
| 08908008085314 | Johari Digital Healthcare Ltd. | SYRMA JOHARI MEDTECH LIMITED | JXK | 2019-04-30 |
| 08908008085321 | 7E Wellness | SYRMA JOHARI MEDTECH LIMITED | JXK | 2019-04-30 |
| M750AR635A0 | CES-Ultra | NEURO-FITNESS LLC | JXK | 2017-06-30 |
| 00857869005239 | TruDenta Earclip Electrode Pad | Electromedical Products International, Inc. | JXK | 2015-06-30 |
| 00857869005161 | Alpha-Stim Earclip Electrode (M) | Electromedical Products International, Inc. | JXK | 2014-08-29 |
| 00857869005178 | Alpha-Stim Earclip Electrode (AID) | Electromedical Products International, Inc. | JXK | 2014-08-29 |
| 00857869005031 | Alpha-Stim Earclip Electrode Pad | Electromedical Products International, Inc. | JXK | 2014-08-25 |
| 00857869005079 | Alpha Conducting Solution | Electromedical Products International, Inc. | JXK | 2014-08-25 |
| 00857869005086 | Alpha Conducting Solution | Electromedical Products International, Inc. | JXK | 2014-08-25 |
| 00857869005093 | Alpha-Stim Earclip Electrode (CE3) | Electromedical Products International, Inc. | JXK | 2014-08-25 |
| 00857869005130 | Alpha-Stim Earclip Electrode (AID) | Electromedical Products International, Inc. | JXK | 2014-08-25 |
cesultra.com