(183 days)
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.
Mentamove is a microprocessor controlled medicotechnical instrument that provides electromyography (EMG)-triggered neuromuscular electrical stimulation ("EMS").
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.
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K 040849
510(k) Summary
| Applicant | Cole & Associates633 Skokie Blvd.Suite 280Northbrook, IL 60062 |
|---|---|
| Manufacturer | pIfR Privat-Institut für Reha-Anwendungen GmbH & Co.Medizintechnik KGFrau KlausLeinorstr. 285757 Karlsfeld |
| Device Name | Mentamove® |
| Common Name | Powered Muscle Stimulator, Biofeedback Device(per 21 CFR 890.5850 and 21 CFR 882.5050) |
| Summary of SubstantialEquivalence | Mentamove® is substantially equivalent in respect to theintended use, design and method of operation of theNeuromove NM900 manufactured by Dan Med, Inc.(K012885). |
| Device Description | Mentamove is a microprocessor controlled medicotechnicalinstrument that provides electromyography (EMG)-triggeredneuromuscular electrical stimulation ("EMS"). |
| Intended Use andIndications | Mentamove is indicated for use in the rehabilitation ofvictims of stroke. It utilizes stroke victims'electromyographic signals to guide the application ofelectrical muscle stimulation. This stimulation helpsstroke victims to relearn voluntary motor functions ofthe extremities. |
| TechnologicalCharacteristics | Mentamove is user-friendly with self-explanatory instructionsfor use via display and therefore simple for the patient to doexercises at home, including automatic adjustment of allpractice parameters and simple electrode placement. Opticalsignal transmission also facilitates the exercise of the patient.Mentamove automatically gauges therapeutic advances of thepatient. Mentamove works with amplitude modulatedelectrical current of middle frequency convenient for thepatient ("soft" electrical current. physiologically adjusted). |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 - 2004
Cole & Associates C/O Richard O. Wood Bell, Boyd & Lloyd, LLP 70 W. Madison St. Suite 3300 Chicago, Illinois 60602
Re: K040849
Trade/Device Name: Mentamove® Regulation Number: 21 CFR 890.5850 and 21 CFR 882.5050 Regulation Name: Powered Muscle Stimulator and Biofeedback Regulatory Class: Class II Product Code: IPF and HCC Dated: September 21, 2004 Received: September 22, 2004
Dear Mr. Wood:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Richard O. Wood
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis iction will and w you've begin finding of substantial equivalence of your device to a legally prematice notification. The Pro Promises
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milliman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K040849 510(k) Number
Mentamove® Device Name:
Indications for 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Image /page/3/Picture/8 description: This image shows a form titled "Concurrence of CDRH, Office of Device Evaluation (ODE)". The form indicates "Prescription Use" with an "X" and includes the text "(Part 21 CFR 801 Subpart D)". The form also includes the text "Division of General, Restorative, and Neurological Devices" and the number "K040849". The document is labeled as "Page 4 of 16" and includes the text "Cole & Associates".
§ 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).