(86 days)
No
The description details standard biofeedback and signal processing features (auto-ranging, targeting with audible signals) but does not mention any AI/ML algorithms for analysis, interpretation, or prediction.
Yes
The "Intended Use / Indications for Use" section explicitly states purposes like "retraining of muscle activation," "coordination of muscle activation," "control and maintenance of muscle contractions," and "relaxation training and muscle re-education," all of which are therapeutic interventions. Additionally, the device's description mentions it being useful for a "healthcare professional," further indicating a therapeutic application.
Yes
The device measures bioelectrical signals produced by muscle activity and provides quantitative measurements. This information can be used to assess muscle activation, coordination, and force production, which are diagnostic purposes to understand the state and function of muscles. While it also mentions "retraining" and "re-education," the measurement of the signals themselves for determination and indication falls under diagnostic use.
No
The device description explicitly states it "measure[s] the bioelectrical signals produced by muscle activity," which requires hardware (electrodes, amplifier, etc.) to acquire these signals. The software component processes and displays this data, but it is not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are performed outside of the body.
- Device Function: The EMG Retrainer measures bioelectrical signals produced by muscle activity directly from the body. It is used for muscle retraining, coordination, force indication, and relaxation training. These are all applications that involve interacting with the body itself, not analyzing samples taken from it.
- Intended Use: The intended uses described are related to muscle function and rehabilitation, not the diagnosis of diseases or conditions through the analysis of bodily fluids or tissues.
- Device Description: The description focuses on measuring electrical signals from muscle, not on analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing bodily fluids, tissues, or any other type of sample typically associated with IVD testing.
Therefore, the EMG Retrainer falls under the category of a medical device used for physiological measurement and therapeutic purposes, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- To determine the activation timing of muscles.
a) retraining of muscle activation
b) coordination of muscle activation - An indication of the force produced by muscle
a) control and maintenance of muscle contractions - For use in relaxation training and muscle re-education.
Product codes
84HCC
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5050 Biofeedback device.
(a)
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.(b)
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.
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597.
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. |
| a) retraining of muscle activation | |
| b) coordination of muscle activation |
- An indication of the force produced by muscle
a) control and maintenance of muscle contractions - 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: 423-870-2281 Fax: 423-874-0287
4
COMPARATIVE SPECIFICATIONS
| Feature | VERIMED | Myotrac | Prometheus
Pathway | Chattanooga
Single & Dual
EMG |
|------------------------|----------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Myoexerciser II | 4001 | MR20 | EMG |
| Pickup Config | individual electrodes | Triangular Pattern | DeLuca in-line
or Proprietary | Triangular or individual
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 | | | | 180 dB | unknown | >100db |
| CMRR
over frequency | 120dB | >130 dB | >110 dB | >120db |
| Input Ranges
(rms) | 8 ranges | 0.8 to 20uV
0.8 to 200uV
0.8 to 2000uV | 1 to 800 uV
true RMS | 1uV to 2000uV
Internal auto gain selection
8 Ranges |
| Electrode Wire | 2 core + Screen | 2 core + Screen | 4 conductors | 2 core + Screen |
| Earpiece | yes | Yes, 2.5mm Phono
8 to 32 Ohm | Yes | Yes
2.5mm Phono |
| Threshold | | Above & Below | Above & Below
& Difference | Above, Below & At Target per
channel |
| Threshold
Features | | N/A | Separate Hi/Lo indicating
Leds | Bar Chart Dynamic Indication,
set by manual, direct activity or
% of activity. |
| Threshold Lock | | 4 seconds then switch to
deactivate | unknown | Yes, Dynamic Threshold
Setting |
| Continuous
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
Compartment | Slide open | Slide open | Slide open | Slide open |
| Power
Consumption | | 6 to 11 mA
Alkaline for 50 hrs | unknown
Battery for 25Hrs | 10 mA w/ Management power
Carbon, Alkaline or Ni Cad |
| Dimensions | 85W140L30H | 61W112L28H | 1176938mm | 81W84L40D |
| 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597.
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. |
| 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. |
(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_