Data / Medical devices / Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety (QJQ): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety (product code QJQ, Class 2, 21 CFR 882.5800). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on December 31, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QJQ
- Device class
- 2
- Regulation
- 882.5800
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| United Kingdom | 2 |
| China | 2 |
| India | 1 |
Makers of Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| FISHER WALLACE LABORATORIES Inc | Brooklyn, NY, United States | Specification developer | 2 | October 4, 1990 | 0 | 1 | 0 | api.fda.gov |
| Neurovalens | Belfast, United Kingdom | Specification developer | 2 | March 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Electromedical Products Intl., Inc. | Mineral Wells, TX, United States | Manufacturer, Specification developer | 1 | May 12, 1992 | 0 | 0 | 0 | api.fda.gov |
| Neuro-Fitness LLC | Fall City, WA, United States | Specification developer | 1 | April 5, 2007 | 0 | 0 | 0 | api.fda.gov |
| Neurofield, Inc. | Santa Barbara, CA, United States | Complaint file establishment, Specification developer | 1 | December 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nexalin Technology, Inc. | Houston, TX, United States | Complaint file establishment, Specification developer | 1 | July 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Syrma Johari MedTech Limited | Jodhpur Rajasthan, India | Manufacturer | 1 | May 29, 2009 | 0 | 0 | 0 | api.fda.gov |
| Apical Instruments | Redwood City, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atr (dongguan) Electronics Manufactory | Tangxia Town, Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Electronic Systems Ltd | Enniskillen Fermanagh and Omagh, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hang Yik Electronics Plastics & Mold (ShenZhen) Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Morgan Newton Company | Plano, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.