Neurotrain
510(k) K883896
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883896 | Date14 Jul 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Neurotrain is an interferential current therapy device. It is classified as a physical medicine device used to deliver electrical stimulation.
This device is manufactured by Sterne Equipment Co., Ltd. and has received FDA 510(k) clearance under K883896. It is regulated as a Class 2 device under regulation number 882.5890.
Other devices from Sterne Equipment Co., Ltd.
Questions
AI-generated answers, 24 Sep 2026
What is the primary function of the Neurotrain device?
The Neurotrain is a physical medicine device designed to deliver electrical stimulation through interferential current therapy.
What is the regulatory status of this device?
The Neurotrain has received FDA 510(k) clearance under K883896 and is regulated as a Class 2 device under regulation number 882.5890.
Who is the manufacturer of the Neurotrain?
The device is manufactured by Sterne Equipment Co., Ltd., located in Brampton, Ontario, Canada.