CES-Ultra
Cranial Electrotherapy Stimulator
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hang Yik Electronics Plastics & Mold (ShenZhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| ATR (Dongguan) Electronics Manufactory | Tangxia Town, Dongguan | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Neuro-Fitness LLC, United States |
|---|---|
| FDA product code | QJQ |
| Device type | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5800 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K062284 |
| Record published | 2017-06-30 |
| Record revised | 2026-05-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR635A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 7E Wellness | Syrma Johari MedTech Limited | 2 |
| Alpha-Stim M | Electromedical Products Intl., Inc. | 2 |
| Johari Digital Healthcare Ltd. | Syrma Johari MedTech Limited | 2 |
| Alpha-Stim AID | Electromedical Products Intl., Inc. | 2 |
| Modius Calm | Neurovalens | 1 |
| Solace Lifesciences, Inc | Syrma Johari MedTech Limited | 1 |
| Genesis | Neurofield, Inc. | 1 |
| Modius Sleep | Neurovalens | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062284 | 2007-04-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.