(1070 days)
Not Found
No
The description focuses on signal recording and display, with no mention of AI/ML algorithms for analysis or interpretation.
No.
The device's description explicitly states "The product does not relay any electrical or stimulatory signals to the body. It is only a signal recorder with display capabilities." Therapeutic devices typically deliver energy or substances to the body to treat a condition. While its output is used for muscle reeducation and relaxation training, the device itself is a diagnostic tool, not a therapeutic one.
No
The device records EMG sensory feedback and displays electrophysiological signals for muscle reeducation and relaxation training, but it does not claim to diagnose any condition.
No
The device description explicitly states it is a portable, battery-powered electronic device that gathers and displays signals via electrodes and transfers data via a fiber optic cable, indicating it is a hardware device with software components, not a software-only device.
Based on the provided information, the Model ME300 Muscle Tester is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- ME300 Function: The ME300 records electrical signals directly from the muscle surface via skin electrodes. It does not analyze or test specimens taken from the body. Its purpose is to provide feedback on muscle activity for reeducation and relaxation training.
- Intended Use: The intended use clearly states "to record EMG sensory feedback signals to be used in various programs of muscle reeducation and relaxation training." This is a therapeutic or rehabilitative use, not a diagnostic one based on analyzing bodily fluids or tissues.
Therefore, the ME300 falls under the category of a medical device, but specifically one that interacts with the body surface to record physiological signals, rather than an IVD.
N/A
Intended Use / Indications for Use
The intended use of the Model ME300 Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle reeducation and relaxation training.
electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training.
Product codes
84HCC
Device Description
The ME300 is a portable, battery powered EMG recorder.
The ME300 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 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.
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
Not Found
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
The ME300 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.
Key Metrics
Not Found
Predicate Device(s)
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.
0
K9435335
510(k) Summary
Class II
JUN 2 5 1997
General Information
Classification
Common Name
Trade Name
Manufacturer
Mega Electronics, Ltd. Savilahdentie 6 PO Box 1750 70211 Kuopio Finland
ME300 Muscle Tester
tel: 358 71 282 8959
Submitted by
Regulatory Strategies, Inc. Consultant to Mega Electronics, Ltd.
Biofeedback device, EMG Device
Predicate Devices
| Myotrac from Thought Technology | K881416 |
|---|---|
| Myoexcerciser from Verimed | K832714 |
Device Description
ﺗﻌﻤ
The ME300 is a portable, battery powered EMG recorder.
Technological Characteristics
The ME300 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 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.
1
Intended Use
The intended use of the Model ME300 Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle reeducation and relaxation training.
Testing
.. .
The ME300 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 ME300 offers the user a means to gather electrophysiological signals (EMG) and display these signals for the purpose of muscle reeducation and relaxation training. The indications for use and the basic overall design are either identical or substantially equivalent to the predicate products.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gregory J. Mathison Requlatory Strategies, Inc. 1660 Riverton Point Eagan, Minnesota -55122 ------------------------------------------------------------------------------------------------------------------------------------------------------
JUN 2 5 1997
Re : K943535 Model ME300 Muscle Tester Trade Name: 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 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 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 OS inspections, the Food and Druq 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 (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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number (if known): K943535
Device Name:
ME300 Muscle Tester
Indications For Use: --------------------------------------------------------------------------------------------------------------------------------------------------------electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahans
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_ K 94 35 35
Prescription Use X (Per 21 CFR 801.109)