NEUROTRON 100

by Neutro-Tronics

510(k) K833086

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K833086↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK833086	Date24 Jan 1984Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K833086
FDA Product Code: GZJ

Device Class: Class II
Regulation: 21 CFR Part 882.5890
Advisory Committee: Neurology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NEUROTRON 100 is a transcutaneous nerve stimulator for pain relief, classified under product code GZJ and regulation 882.5890. It is a device intended for use in neurology to deliver electrical stimulation through the skin to modulate pain signals.

The device received traditional 510(k) clearance from the FDA on January 24, 1984, under K833086, and is classified as a Class II medical device. It was submitted by Neutro-Tronics and is authorized for marketing in the United States based on substantial equivalence to a predicate device.