MYO-TRAIN V (5)

• K Number: K980158
• Device Name: MYO-TRAIN V (5)
• Manufacturer: STERNE EQUIPMENT CO., LTD.
• Date Cleared: 1998-07-28 ( 193 days)
• Product Code: IPF DAT
• Regulation Number: 890.5850

Intended Use

The Myo-train V may be used for the following indications: - 1) Relaxation of muscle spasm. - Prevention or retardation of disuse atrophy. 2) - Increasing local blood circulation. 3) - 4) Muscle re-education. - Maintaining or increasing range of motion. 5)

Device Description

Not Found

Predicate Devices

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Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text does not contain any keywords or descriptions related to AI or ML technology.

Therapeutic

Yes
The "Intended Use / Indications for Use" section lists several therapeutic applications such as "Relaxation of muscle spasm," "Prevention or retardation of disuse atrophy," and "Muscle re-education."

Diagnostic

No
The provided text lists therapeutic indications such as muscle relaxation, prevention of atrophy, increasing blood circulation, muscle re-education, and maintaining / increasing range of motion, but it does not mention any diagnostic functions.

SaMD (Software as a Medical Device)

Unknown

The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. Without this information, it's impossible to definitively classify the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The listed indications for use (muscle relaxation, preventing atrophy, increasing blood circulation, muscle re-education, maintaining range of motion) are all related to physical therapy and rehabilitation, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
• 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.)
  • Detecting or measuring substances in those samples
  • Providing diagnostic information based on laboratory tests

The Myo-train V appears to be a device used for physical therapeutic purposes, likely involving electrical stimulation or similar modalities to affect muscles directly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Myo-train V may be used for the following indications:

• 1. Relaxation of muscle spasm.
• Prevention or retardation of disuse atrophy. 2)
• Increasing local blood circulation. 3)
• 4. Muscle re-education.
• Maintaining or increasing range of motion. 5)

Product codes

IPFF

Device Description

Not Found

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

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Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines that suggest the head and wings.

JUL 28 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas Wallace Technical Director Sterne Equipment Company Limited 7 Research Road Brampton, Ontario L6W 1P4

Re: K980158 Trade Name: Myo-train V (5) Requlatory Class: II IPFF Product Code: Dated: April 28, 1998 April 29, 1998 Received:

Dear Mr. Wallace:

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 legally marketed predicate 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, Druq, 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 requlations 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 requirements, 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 requlation 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 - Mr. Thomas Wallace

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" (21CFR 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/dsma/dsmamain.html".

sincerely yours,

la M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(K) Number: NA

Device Name: MYO-TRAIN V

INDICATIONS FOR USE

The Myo-train V may be used for the following indications:

• 1. Relaxation of muscle spasm.
• Prevention or retardation of disuse atrophy. 2)
• Increasing local blood circulation. 3)
• 4. Muscle re-education.
• Maintaining or increasing range of motion. 5)

tcoself

(Division Sign-Off) Division of General Restorative Devices 1980158 510(k) Number

Prescription Use (Pe: _ 1 CFR 801.109)