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Insight

by Staodynamics, Inc.

510(k) K811345

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811345 Date10 Jul 1981ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
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 Insight is a Stimulator, Nerve, Transcutaneous, For Pain Relief, classified under FDA product code GZJ. This device delivers transcutaneous electrical nerve stimulation (TENS) to alleviate pain by modulating nerve signals through low-voltage electrical impulses applied to the skin.

Intended for clinical use in neurology settings, the Insight is supplied as a reusable medical device. It requires no sterility beyond standard electrical safety standards and is regulated under FDA 510(k) clearance (K811345) with a decision of Substantially Equivalent (SESE). No specific MRI safety or single-use requirements are noted in the regulatory filings.

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