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CMAP PRO

by Medical Technologies, Inc. 510(k)

Active United States

510(k) K113074

Overview

The CMAP PRO is a diagnostic electromyograph device used in physical medicine. It is designed to obtain data through the use of surface EMG electrodes in combination with motion detection technology.

The device is supplied as a reusable system and was cleared via the FDA 510(k) process under K113074 with a substantially equivalent decision. It is classified as a Class II device under regulation 890.1375, with product code IKN, and is intended for use in clinical settings for neuromuscular assessment.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113074 Date2 Feb 2012ClearedStatusActive

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
IKN
Device Class
Class II
Regulation
21 CFR Part 890.1375
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the CMAP PRO used for?

    The CMAP PRO is a diagnostic electromyograph device used in physical medicine to obtain neuromuscular assessment data through surface EMG electrodes combined with motion detection technology in clinical settings.

  • Is the CMAP PRO reusable or single-use?

    The CMAP PRO is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and maintenance between patient applications.

  • How was the CMAP PRO cleared for market?

    The CMAP PRO was cleared via the FDA 510(k) process under submission K113074, receiving a substantially equivalent decision based on its technological characteristics and intended use.

  • What regulatory classification does the CMAP PRO have?

    The CMAP PRO is classified as a Class II medical device under FDA regulation 890.1375, with product code IKN, indicating its risk level and regulatory controls for diagnostic electromyographs.