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
• Type: Special
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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

AI/ML Overview

This document is a 510(k) substantial equivalence determination letter from the FDA for a medical device called the "Rich-Mar Winner CM-2". It does not contain information about acceptance criteria, device performance, or details of a study with sample sizes, expert qualifications, or ground truth establishment.

Here's why the requested information cannot be found in the provided text:

• Nature of the Document: This letter is an FDA approval (or clearance) document, indicating that the device has been deemed "substantially equivalent" to predicate devices already on the market. It confirms that the device can be legally marketed. It is not a report detailing the results of clinical trials, performance studies, or validation efforts.
• Focus on Equivalence: The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove absolute efficacy or performance against a set of predefined acceptance criteria through a specific study. While manufacturers perform testing to support their claims, the FDA letter itself doesn't typically provide those detailed results.
• Missing Sections: The document lacks sections such as "Study Design," "Methods," "Results," "Performance Metrics," or "Clinical Data," which would be present in a study report.

Therefore, I cannot extract the requested information (table of acceptance criteria, device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, types of ground truth, training set size, or ground truth establishment for the training set) from this document.

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

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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

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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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Regulation Number and Section

N/A