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Myotrac

by Thought Technology Ltd.

510(k) K881416

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K881416↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK881416 Date26 Sep 1988ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K881416 decided 26 Sep 1988 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 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 Myotrac is a biofeedback device designed to monitor and provide real-time feedback on muscle activity. It is classified as a biofeedback device and is used primarily for neurological applications, enabling users to observe and control physiological signals related to muscle function, often for therapeutic or research purposes.

The Myotrac is supplied as a reusable medical device and is intended for use in clinical or research settings. It operates under FDA 510(k) clearance and MDD authorization, adhering to regulatory standards for biofeedback devices. The device is not specified as MRI-safe or single-use, and its storage conditions are not detailed in the provided data. It is categorized under device class 2 and is associated with neurology specialties.

Devices cleared under K881416

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K881416
UDI-DISize and differences
Myotrac 4000 60Hz Unit PP SA4000P
Thought Technology Ltd.
SA4000P07540191000012 —On the market
Sensor, Myoscan EMG SA9503M
Thought Technology Ltd.
SA9503M07540191000227 —On the market

Similar devices

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

Other devices from Thought Technology Ltd.

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