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Emg 3510/EMG 3510D Myofeedback Monitors

by Atlas Researches, Ltd. 510(k)

Active United States

510(k) K810881

Overview

The Emg 3510/Emg 3510d Myofeedback Monitors are biofeedback devices. They are classified as device class 2, with a regulation number of 882.5050, and are used in the medical specialty of Neurology.

The devices are supplied by Atlas Researches, Ltd. and have FDA 510K clearance, with a product code of HCC. They were cleared on May 27, 1981, with the k number K810881.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK810881 Date27 May 1981ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HCC
FDA applicant
Atlas Researches , Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.5050
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Atlas Researches, Ltd.

Questions

  • What is the EMG 3510/EMG 3510D Myofeedback Monitor used for?

    The EMG 3510/EMG 3510D Myofeedback Monitor is a biofeedback device used in the medical specialty of neurology to provide myofeedback, helping patients gain awareness and control over muscle activity through real-time electromyographic signals.

  • How is the EMG 3510/EMG 3510D Myofeedback Monitor supplied and is it sterile or reusable?

    The device is supplied by Atlas Researches, Ltd. as a non-sterile, reusable biofeedback monitor intended for multiple uses in clinical settings; it does not require sterilization between uses as it is designed for external surface EMG applications with proper cleaning protocols.

  • What regulatory pathway was used for the EMG 3510/EMG 3510D Myofeedback Monitor and when was it cleared?

    The EMG 3510/EMG 3510D Myofeedback Monitor received FDA 510K clearance through the traditional pathway on May 27, 1981, under K number K810881, demonstrating substantial equivalence to a legally marketed predicate device.