MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE

• K Number: K013771
• Device Name: MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
• Manufacturer: RICH-MAR CORP.
• Date Cleared: 2002-01-18 ( 66 days)
• Product Code: IPF GZJ IMG IMI LIH
• Regulation Number: 890.5850

Intended Use

Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms: 1. Relaxation of muscle spasms. 2. Prevention or retardation of disuse atrophy. 3. Increasing local blood circulation. 4. Muscle re-education. 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms: 1. Symptomatic relief of chronic intractable pain. 2. Management of pain associated with post-traumatic or post operative conditions. Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions: 1. Relief of pain 2. Muscle spasms 3. Joint contractures But NOT for the treatment of malignancies

Device Description

Not Found

Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text describes a muscle stimulator and ultrasound device with various waveforms and indications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided sections.

Therapeutic

Yes
The device is indicated for therapeutic uses such as relaxation of muscle spasms, relief of pain, increasing local blood circulation, and prevention of venous thrombosis.

Diagnostic

No
The provided text lists indications for treatment and therapeutic uses (e.g., relaxation of muscle spasms, pain relief, increasing local blood circulation), but it does not mention any function for identifying, analyzing, or determining the presence or nature of a disease or condition. The device's purpose is therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

No

The provided text only describes the intended use and indications for a muscle stimulator and ultrasound devices. It does not contain a device description, which is necessary to determine if the device is software-only. The indications strongly suggest hardware components are involved (muscle stimulation requires electrodes, ultrasound requires a transducer).

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The description clearly states the device is a muscle stimulator and ultrasound device. Its intended uses involve applying electrical stimulation and therapeutic heat directly to the body for various physical therapy and pain management purposes.
• Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.

Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:

• 1. Relaxation of muscle spasms.
• 2. Prevention or retardation of disuse atrophy.
• 3. Increasing local blood circulation.
• 4. Muscle re-education.
• 5. Maintaining or increasing range of motion.
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. 6.

Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:

• 1. Symptomatic relief of chronic intractable pain.
• 2. Management of pain associated with post-traumatic or post operative conditions.

Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

• l. Relief of pain
• 2. Muscle spasms
• 3. Joint contractures
     But NOT for the treatment of malignancies

Product codes

IPF, IMI, IMG, GZJ, LIH

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

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Input Imaging Modality

Not Found

Anatomical Site

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Indicated Patient Age Range

Not Found

Intended User / Care Setting

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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

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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

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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2002

Mr. David Richards Vice President. Director of Regulatory Affairs Rich-Mar Corporation P.O. Box 879 Inola, Oklahoma 74036-0879

Re: K013771/S1

Trade/Device Name: Winner CM-2 Regulation Numbers: 21 CFR 890.5850, 890.5300(a), 890.5860(a), and 882.5890 Regulation Names: Powered Muscle Stimulator, Ultrasonic Diathermy, Ultrasound and Muscle Stimulator, and Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Codes: IPF, IMI, IMG, GZJ and LIH Dated: December 13, 2001 Received: January 7, 2002

Dear Mr. Richards:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration

1

Page 2 - Mr. David Richards

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate devices 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

L. Mark N. Melkman

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

Enclosure

2

l of l Page

510(k) Number (if known): K013771

Device Name: Rich-Mar Winner CM2

Indications For Use:

Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms:

• 1. Relaxation of muscle spasms.
• 2. Prevention or retardation of disuse atrophy.
• 3. Increasing local blood circulation.
• 4. Muscle re-education.
• 5. Maintaining or increasing range of motion.
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. 6.

Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms:

• 1. Symptomatic relief of chronic intractable pain.
• 2. Management of pain associated with post-traumatic or post operative conditions.

Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:

• l. Relief of pain
• 2. Muscle spasms
• 3. Joint contractures

But NOT for the treatment of malignancies

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark n Mill
(Division Sign-Off)
Γ.ision of General, Restorative
Neurological Devices

Number K013771

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