EMG RETRAINER

K972487 · Chattanooga Group, Inc. · HCC · Sep 26, 1997 · Neurology

Device Facts

• Record ID: K972487
• Device Name: EMG RETRAINER
• Applicant: Chattanooga Group, Inc.
• Product Code: HCC · Neurology
• Decision Date: Sep 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

1. To determine the activation timing of muscles. a) retraining of muscle activation b) coordination of muscle activation 2. An indication of the force produced by muscle a) control and maintenance of muscle contractions 3. For use in relaxation training and muscle re-education.

Device Story

Portable EMG device measures bioelectrical muscle signals via surface electrodes; processes signals to provide quantitative feedback. Features auto-ranging for signal scaling; custom LCD displays analog bar charts of muscle activity. Includes audible tone feedback for target muscle activity levels (within or exceeding limits). Used by healthcare professionals for muscle re-education, relaxation training, and coordination exercises. Provides real-time visual and auditory feedback to assist patients in controlling muscle tension; enables monitoring of training progress via stored session data.

Clinical Evidence

No clinical data provided; bench testing only. Comparative specifications provided against predicate devices regarding input impedance, CMRR, frequency ranges, and display features.

Technological Characteristics

Portable EMG monitor; 1 or 2 channels; 15Hz-300Hz frequency range (12dB/Octave filter); >100dB CMRR at 50/60Hz; >120dB CMRR over frequency; 1uV-2000uV input range; 1,000,000 M Ohm input impedance. Custom LCD display; silicone keypad controls; 3V battery power (AA cells).

Indications for Use

Indicated for patients requiring muscle re-education, relaxation training, coordination of muscle activation, and monitoring of muscle contraction force.

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

• The Prometheus Group Pathway II Electromyography (K891732)
• Verimed Myoexerciser II (K892649)

Reference Devices

• Thought Technology Myotrac (K915858)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized eagle emblem, with three curved lines representing the eagle's body and wings. The emblem is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 1997

Mr. Joe Elrod Manager of Regulatory Affairs Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 37343-0489 Hixson, Tennessee

K972487 Re : EMG Retrainer Trade Name: Regulatory Class: II 84HCC Product Code: June 5, 1997 Dated: Received: July 2, 1997

Dear Mr. Elrod:

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 A substantially equivalent determination assumes compliance to 895. with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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

{1}------------------------------------------------

Page 2 - Mr. Joe Elrod

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 requlations.

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 at [phone].

Sincerely yours,

Thomas J. Callahion

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

Enclosure

{2}------------------------------------------------

### 510(k) Number (if known): K972487

| Device Name: | Chattonooga Group, Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | 1. To determine the activation timing of muscles.<br>a) retraining of muscle activation<br>b) coordination of muscle activation<br>2. An indication of the force produced by muscle<br>a) control and maintenance of muscle contractions<br>3. For use in relaxation training and muscle re-education. |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Atte Heif for DB Stillman

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K 972487

Over-The-Counter Use _________

Prescription Use X (Per 21 CFR 801.109)

OR

{3}------------------------------------------------

K972487
Sept. 26, 1997
**510(K) SUMMARY**

CHATTANOOGA
GROUP, INC.

June 5, 1997 Date: Contact Person: Joe Elrod EMG Retrainer Product: Diagnostic Electromyograph Classification Name: Class II Classification:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Substantial Equivalence: The new device is a stand alone portable device for the measurement of muscle activity. It is similar to The Prometheus Group Pathway II Electromyography (510(k) K891732), Verimed Myoexerciser II (510(k) K892649), Reference Comparative and Thought Technology Myotrac (510(k) K915858). Specifications on page 2-2}.

System Description: The EMG Retrainer is a device used to measure the bioelectrical signals produced by muscle activity. The main display will register activity and display the quantitative measurement with an analog bar display. Targets of muscle activity may be stored (utilizing audible signals on demand) configurable for activity that is within established limits or exceeding those limits depending on user preference. The EMG Retrainer also contains an auto-ranging function which eliminates manual scale adjustments unless that is the preference. The auto-ranging feature as well as the targeting function are not available on the other models and will be quite useful to the healthcare professional.

Intended Use: The EMG Retrainer measures electrical activity of the muscle . Since the electrical activity of the muscle increases as the muscle tension increases and decreases as muscle tension decreases, EMG can provide information about the state of muscle tension.

> Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 Hixson, TN 37343-0489 Phone: [phone] Fax: [phone]

{4}------------------------------------------------

# COMPARATIVE SPECIFICATIONS

| Feature | VERIMED | Myotrac | Prometheus<br>Pathway | Chattanooga<br>Single & Dual<br>EMG |
|------------------------|----------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Myoexerciser II | 4001 | MR20 | EMG |
| Pickup Config | individual electrodes | Triangular Pattern | DeLuca in-line<br>or Proprietary | Triangular or individual<br>electrodes |
| Active Head | No | Yes | Yes for Proprietary | No |
| Input Imped. | >10M ohm | 1,000,000 M ohm | unknown | 1,000,000 M Ohm with 4pF |
| Input Noise | | | | <1uV RMS |
| Display Type | 4 lines x 20 characters<br>5 lines x 25 characters | 13 LED Dot Bar chart | 16 char LCD histograms<br>with log output<br>4 LED s | Custom LCD, dual 25 Seg Bar<br>Chart<br>plus overflows, 3 by 7seg digit<br>signal level per channel, plus<br>volume, & progr. Select digit |
| Operator Controls | 12 Membrane Buttons | Volume & Gain Knobs<br>Range Slide Switch<br>Mode/On/Off switch | 6 Membrane Buttons | 5 Silicone Keypad Buttons;<br>On/Off;<br>Up, Down, Select & OK |
| Channels | 2 | 1 | 2 | 1 or 2 |
| Frequency Ranges | 25 to 1000Hz | 100 to 200Hz<br>20 to 500Hz | 20 to 500 Hz<br>"no notch filter" | 15Hz to 300Hz<br>(12db/Octave filter) |
| Buzzer | yes | Yes | Yes | 3 Tone |
| Output Voltage | yes | Yes 0 to 2V | No (data by comms) | No |
| CMRR<br>50 Hz, 60 Hz | 140dB | >180 dB | unknown | >100db |
| CMRR<br>over frequency | 120dB | >130 dB | >110 dB | >120db |
| Input Ranges<br>(rms) | 8 ranges | 0.8 to 20uV<br>0.8 to 200uV<br>0.8 to 2000uV | 1 to 800 uV<br>true RMS | 1uV to 2000uV<br>Internal auto gain selection<br>8 Ranges |
| Electrode Wire | 2 core + Screen | 2 core + Screen | 4 conductors | 2 core + Screen |
| Earpiece | yes | Yes, 2.5mm Phono<br>8 to 32 Ohm | Yes | Yes<br>2.5mm Phono |
| Threshold | | Above & Below | Above & Below<br>& Difference | Above, Below & At Target per<br>channel |
| Threshold<br>Features | | N/A | Separate Hi/Lo indicating<br>Leds | Bar Chart Dynamic Indication,<br>set by manual, direct activity or<br>% of activity. |
| Threshold Lock | | 4 seconds then switch to<br>deactivate | unknown | Yes, Dynamic Threshold<br>Setting |
| Continuous<br>Alarm | Yes, Varying pulse rates | Yes | unknown | Yes, Varying pulse rates |
| Stimulator | yes | No | Isolated Relay | No |
| Historical Record | yes | N/A | 32 Training Sessions | 9 training sessions |
| Battery Type | 9V | 9V | 9V | 3V Using AA cells |
| Battery<br>Compartment | Slide open | Slide open | Slide open | Slide open |
| Power<br>Consumption | | 6 to 11 mA<br>Alkaline for 50 hrs | unknown<br>Battery for 25Hrs | 10 mA w/ Management power<br>Carbon, Alkaline or Ni Cad |
| Dimensions | 85W*140L*30H | 61W*112L*28H | 117*69*38mm | 81W*84L*40D |
| Weight | 180g | 70 g+bat. | 280g | 150g |
| Pocket Clip | Yes | Yes | Yes | Yes |

ﺮ

{5}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 1997

Mr. Joe Elrod Manager of Regulatory Affairs Chattanooga Group, Inc. 4717 Adams Road P.O. Box 489 Hixson, Tennessee 37343-0489

K972487 Re : EMG Retrainer Trade Name: Regulatory Class: II Product Code: 84HCC June 5, 1997 Dated: Received: July 2, 1997

Dear Mr. Elrod:

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

{6}------------------------------------------------

Page 2 - Mr. Joe Elrod

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.

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 requlation (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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone].

Sincerely yours,

Thomas J. Callahon

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

Enclosure

{7}------------------------------------------------

### 510(k) Number (if known): K972487

| Device Name: | Chattanooga Group, Inc. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | 1. To determine the activation timing of muscles.<br>a) retraining of muscle activation<br>b) coordination of muscle activation |
| | 2. An indication of the force produced by muscle<br>a) control and maintenance of muscle contractions |
| | 3. For use in relaxation training and muscle re-education. |

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for DB Tillman

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number 972487

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use_