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Myoexorciser II Fual

by Verimed Holdings, Inc.

510(k) K951969

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 NumberK951969 Date14 Jun 1995ClearedStatusActive

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  • Withdrawn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, 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 Myoexorciser II Fual is a biofeedback device designed to assist in the assessment and treatment of neuromuscular function. It provides real-time feedback to help users monitor and control muscle activity, particularly in neurological rehabilitation settings.

This device is intended for use in clinical environments and is classified as a Class II medical device under FDA regulations. It is supplied as a reusable instrument and requires proper sterilization between uses. The Myoexorciser II Fual holds an FDA 510(k) clearance (K951969) and is regulated under the regulation number 882.5050, with a product code of HCC.

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