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EMG 100T

by Thought Technology Ltd.

510(k) K822814

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822814 Date8 Oct 1982ClearedStatusActive

Official records

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  • Withdrawn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
HCC
FDA applicant
Thought Technology , Ltd.
Device class
Class II
Regulation
21 CFR Part 882.5050
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 EMG 100T is a biofeedback device classified under product code HCC and regulation number 882.5050. It is a substantially equivalent device cleared through the traditional 510(k) pathway with K number K822814.

The device is manufactured by Thought Technology Ltd. and is authorized for use in the United States. It falls under the neurology advisory committee classification and is intended for use as a biofeedback instrument in clinical or professional settings.

Similar devices

Other devices filed under FDA product code HCC (Device, Biofeedback).

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