Trans-Q

by Chesapeake Medical Assoc.

510(k) K821363

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) K821363↗

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	NumberK821363	Date28 May 1982Cleared	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Withdrawn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: K821363
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, 19 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 Trans-Q is a transcutaneous electrical nerve stimulation (TENS) device, classified under product code GZJ. It delivers low-voltage electrical currents to the skin for pain management, targeting nerve pathways to alleviate discomfort without systemic drug administration.

Supplied as a reusable device, the Trans-Q is intended for clinical use in settings such as physician offices or outpatient care. It requires no sterility beyond standard cleaning protocols between patients and is not designed for MRI environments. Authorized under FDA 510(k) clearance (K821363), it was originally submitted to the Neurology Advisory Committee in 1982 and remains compliant with traditional review standards.