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K Number
K040849
Device Name
MENTAMOVE
Manufacturer
COLE & ASSOCIATES
Date Cleared
2004-10-01

(183 days)

Product Code
IPF
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
K012885
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Mentamove is indicated for use in the rehabilitation of victims of stroke. It utilizes stroke victims' electromyographic signals to guide the application of electrical muscle stimulation. This stimulation helps stroke victims to relearn voluntary motor functions of the extremities.

Device Description

Mentamove is a microprocessor controlled medicotechnical instrument that provides electromyography (EMG)-triggered neuromuscular electrical stimulation ("EMS").

AI/ML Overview

The provided text does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary and FDA clearance letter for the Mentamove® device, establishing its substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table and study details. The available information primarily focuses on:

  • Applicant and Manufacturer: Cole & Associates and pIfR Privat-Institut für Reha-Anwendungen GmbH & Co.
  • Device Name: Mentamove®
  • Common Name and Classification: Powered Muscle Stimulator, Biofeedback Device (Class II)
  • Predicate Device: Neuromove NM900 (K012885)
  • Device Description: Microprocessor controlled medicotechnical instrument providing electromyography (EMG)-triggered neuromuscular electrical stimulation ("EMS").
  • Intended Use and Indications: Rehabilitation of stroke victims to relearn voluntary motor functions of the extremities by using EMG signals to guide electrical muscle stimulation.
  • Technological Characteristics: User-friendly, self-explanatory instructions, automatic adjustment of parameters, simple electrode placement, optical signal transmission, automatic gauging of therapeutic advances, amplitude modulated electrical current.
  • FDA Clearance: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

To answer your specific questions, information from clinical trials, verification and validation studies, or performance testing would be required, which is not present in the provided 510(k) summary.

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).