(364 days)
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Not Found
No
The summary provides no indication of AI/ML technology being used. The description is very basic and focuses on the device's function for muscle re-education and relaxation. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is intended for "re-education and relaxation of the muscles," which are therapeutic applications.
No
The intended use states the device is for "re-education and relaxation of the muscles", which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it is a "battery powered device," indicating it includes hardware components beyond just software.
Based on the provided information, the Muscle Response Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "re-education and relaxation of the muscles in the hand." This describes a therapeutic or rehabilitative purpose, not a diagnostic one.
- Device Description: The description is of a battery-powered device, which is consistent with a physical therapy or biofeedback device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a disease or condition
- Using reagents or assays
IVDs are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Muscle Response Monitor's function is related to muscle function and control, which falls outside the scope of IVD regulation.
N/A
Intended Use / Indications for Use
The Muscle Response Monitor is a battery powered device that has been developed for re-education and relaxation of the muscles in the hand.
Product codes
GWP, IQH
Device Description
The Muscle Response Monitor is a battery powered device that has been developed for re-education and relaxation of the muscles in the hand.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Not Found
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads facing right, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Lou Wilson ·President Enriching Your Life 6339 Kelly Drive Grandbury, Texas 76048
APR 1 4 1998
Re: K971400 Trade Name: Muscle Response Monitor Regulatory Class: II Product Code: GWP and IQH Dated: January 10, 1998 Received: January 14, 1998
Dear Ms. Wilson:
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. ਸਿ substantially equivalent determination assumes compliance with ... _ the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 - Ms. Wilson
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) 594-4595. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours;
Styhin Rhoobs
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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0.alre 403758 Triam 11.1
April 13, 1998
K971400 510(k) Number (if known):
Muscle Response Monitor Device Name:
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Indications For Use:
The Muscle Response Monitor is a battery powered device that has been developed for re-education and relaxation of the muscles in the hand.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative Devices K971400 · 510(k) Number
Prescription Use (Per EFR 801.109)
OR
Over-The-Counter Use
(Optional Formst 1-2-96)