MEGA ME 3000 PROFESSIONAL MUSCLE TESTER

K963202 · Mega Electronics , Ltd. · HCC · May 19, 1997 · Neurology

Device Facts

• Record ID: K963202
• Device Name: MEGA ME 3000 PROFESSIONAL MUSCLE TESTER
• Applicant: Mega Electronics , Ltd.
• Product Code: HCC · Neurology
• Decision Date: May 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2

Intended Use

The intended use of the Model ME3000P Professional Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle re-education and relaxation training.

Device Story

ME3000P is a portable, battery-powered EMG recorder. It captures electrophysiological signals from muscle activity via conductive adhesive skin electrodes. The device supports two or more channels. It functions solely as a signal recorder and display unit; it does not deliver electrical or stimulatory signals to the body. Data is transferred to a PC via fiber optic cable for storage or display. Used in clinical settings for muscle re-education and relaxation training programs. Healthcare providers use the displayed EMG feedback to guide patient therapy, assisting in muscle control and relaxation.

Clinical Evidence

Bench testing only. The device was tested for electrical and EMC safety by a recognized third-party facility, meeting requirements of IEC 601-1-2, IEC 801-2, IEC 801-3, and EN55011.

Technological Characteristics

Portable, battery-powered EMG recorder. Uses conductive adhesive skin electrodes for signal acquisition. Features two or more channels. Data transfer to PC via fiber optic cable. Complies with IEC 601-1-2, IEC 801-2, IEC 801-3, and EN55011 standards.

Indications for Use

Indicated for patients requiring muscle re-education and relaxation training via EMG sensory feedback.

Regulatory Classification

Identification

A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

Predicate Devices

• Myotrac from Thought Technology (K881416)
• Myoexcerciser from Verimed (K832714)
• Myosystem 1000/2000 from Noraxon (K895635)

Submission Summary (Full Text)

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K963002
MAY 19 1997

# 510(k) Summary

## General Information

| Classification | Class II |
| --- | --- |
| Common Name | Biofeedback device, EMG Device |
| Trade Name | ME3000P Professional Muscle Tester |
| Manufacturer | Mega Electronics, Ltd.
Savilahdentie 6
PO Box 1750
70211 Kuopio
Finland
tel: [phone] |
| Submitted by | Regulatory Strategies, Inc.
Consultant to Mega Electronics, Ltd. |

## Predicate Devices

| Myotrac from Thought Technology | K881416 |
| --- | --- |
| Myoexcerciser from Verimed | K832714 |
| Myosystem 1000/2000 from Noraxon | K895635 |

## Device Description

The ME3000P is a portable, battery powered EMG recorder.

## Technological Characteristics

The ME3000P is an electronic device used to gather and display electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training.

The signals are received via conductive adhesive skin electrodes and may be displayed or stored for display at a later time. Signals may be gathered from two or more channels. Data downloading or transfer is via a standard fiber optic cable to a PC. The product does not relay any electrical or stimulatory signals to the body. It is only a signal recorder with display capabilities.

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## Intended Use

The intended use of the Model ME3000P Professional Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle re-education and relaxation training.

## Testing

The ME300P was tested for electrical and EMC safety by a recognized third party testing facility. The product meets the requirements of IEC 601-1-2, IEC 801-2, IEC 801-3, EN55011 and the EMC Directive.

## Summary of Equivalence

The ME3000P offers the user a means to gather electrophysiological signals (EMG) and display these signals for the purpose of muscle re-education and relaxation training. The indications for use and the basic overall design are either identical or substantially equivalent to the predicate products.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

# MAY 19 1997

Mr. Gregory J. Mathison
President
Regulatory Strategies, Inc.
1660 Riverton Point
Eagan, Minnesota 55122-3138

Re: K963202
Trade Name: ME3000P Professional Muscle Tester
Regulatory Class: II
Product Code: 84HCC
Dated: March 28, 1997
Received: March 28, 1997

Dear Mr. Mathison:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: -General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Gregory J. Mathison

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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510(k) Number: K963202

Device Name: ME3000P Professional Muscle Tester

Indications for Use:

The intended use of the Model ME3000P Professional Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle re-education and relaxation training

Thomas J. Callahan

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K963202

Prescription Use ☑

Per 21 CFR 801.109)