MENTAMOVE

K040849 · Cole & Associates · IPF · Oct 1, 2004 · Physical Medicine

Device Facts

• Record ID: K040849
• Device Name: MENTAMOVE
• Applicant: Cole & Associates
• Product Code: IPF · Physical Medicine
• Decision Date: Oct 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Mentamove is a microprocessor-controlled device for EMG-triggered neuromuscular electrical stimulation (EMS). It captures electromyographic (EMG) signals from the patient's muscles; these signals trigger the application of electrical muscle stimulation to assist in relearning voluntary motor functions. Designed for home use by patients, the device features a display for self-explanatory instructions, simple electrode placement, and optical signal transmission to guide exercises. It automatically adjusts practice parameters and gauges therapeutic progress. The device delivers amplitude-modulated, middle-frequency electrical current, described as 'soft' and physiologically adjusted, to facilitate patient comfort. By providing feedback and stimulation based on the patient's own muscle activity, the device aims to support motor function recovery in stroke survivors.

Technological Characteristics

Microprocessor-controlled EMG-triggered neuromuscular electrical stimulator. Delivers amplitude-modulated, middle-frequency electrical current. Features include a user display, optical signal transmission, and automatic parameter adjustment. Designed for home use.

Indications for Use

Indicated for stroke victims requiring rehabilitation to relearn voluntary motor functions of the extremities.

Regulatory Classification

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.

Predicate Devices

• Neuromove NM900 (K012885)

Submission Summary (Full Text)

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## K 040849

## 510(k) Summary

| Applicant | Cole & Associates<br>633 Skokie Blvd.<br>Suite 280<br>Northbrook, IL 60062 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | pIfR Privat-Institut für Reha-Anwendungen GmbH & Co.<br>Medizintechnik KG<br>Frau Klaus<br>Leinorstr. 2<br>85757 Karlsfeld |
| Device Name | Mentamove® |
| Common Name | Powered Muscle Stimulator, Biofeedback Device<br>(per 21 CFR 890.5850 and 21 CFR 882.5050) |
| Summary of Substantial<br>Equivalence | Mentamove® is substantially equivalent in respect to the<br>intended use, design and method of operation of the<br>Neuromove NM900 manufactured by Dan Med, Inc.<br>(K012885). |
| Device Description | Mentamove is a microprocessor controlled medicotechnical<br>instrument that provides electromyography (EMG)-triggered<br>neuromuscular electrical stimulation ("EMS"). |
| Intended Use and<br>Indications | Mentamove is indicated for use in the rehabilitation of<br>victims of stroke. It utilizes stroke victims'<br>electromyographic signals to guide the application of<br>electrical muscle stimulation. This stimulation helps<br>stroke victims to relearn voluntary motor functions of<br>the extremities. |
| Technological<br>Characteristics | Mentamove is user-friendly with self-explanatory instructions<br>for use via display and therefore simple for the patient to do<br>exercises at home, including automatic adjustment of all<br>practice parameters and simple electrode placement. Optical<br>signal transmission also facilitates the exercise of the patient.<br>Mentamove automatically gauges therapeutic advances of the<br>patient. Mentamove works with amplitude modulated<br>electrical current of middle frequency convenient for the<br>patient ("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 [phone]. 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 [phone] or [phone] 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.

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