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Biofeedback Device EMG1, EMG Ultra Low Noise Opti

by Moe

510(k) K884852

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 NumberK884852 Date2 Feb 1989ClearedStatusActive

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  • Withdrawn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
HCC
Device Class
Class II
Regulation
21 CFR Part 882.5050
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters so that the patient can control voluntarily these physiological parameters. This device is classified as a Device, Biofeedback under product code HCC and is intended for use in the field of Neurology.

It received FDA 510(k) clearance (K884852) on February 2, 1989, following a traditional submission process. The device is classified as Class II and is manufactured by Moe. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or specific clinical indications is provided in the data.

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