WINNER CM4 COMBINATION UNIT

• K Number: K012848
• Device Name: WINNER CM4 COMBINATION UNIT
• Manufacturer: RICH-MAR CORP.
• Date Cleared: 2001-10-25 ( 63 days)
• Product Code: GZJ , IPF , LIH
• Regulation Number: 882.5890
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

THERAPEUTIC ULTRASOUND
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

MICROAMPERAGE PULSED CURRENT INDICATIONS FOR TREATMENT (Microcurrent)
Microcurrent output is indicated for the following conditions:

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

Quadpolar, Bipolar, Monophasic and Russian Waveforms
This device is indicated for the following conditions:

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.
   Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

(Quadpolar Interferential and Microamperage Pulsed Current)

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

Device Description

Not Found

AI/ML Overview

This is a 510(k) clearance letter for the Rich-Mar Winner CM4 device, which is a combination of several therapeutic modalities including powered muscle stimulator, TENS, ultrasonic diathermy, ultrasound and muscle stimulator, and interferential current therapy.

The document does not describe a study involving AI or machine learning algorithms, nor does it provide acceptance criteria and performance data in the typical format for such studies. This letter is a regulatory document confirming substantial equivalence to predicate devices, not a performance study report for a novel AI-powered device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truthing, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text. The document pertains to a medical device's regulatory clearance based on its similarity to previously approved devices, not on the performance of an AI component.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of text surrounding a stylized image of an eagle. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters. The eagle is depicted with three lines forming its wings and body, giving it a modern and abstract appearance.

OCT 2 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K012848 Trade/Device Name: Rich-Mar Winner CM4 Regulation Number: 890.5850, 882.5890, 890.5300, 890.5860 Regulation Name: Powered muscle stimulator Transcutaneous electrical nerve stimulator Ultrasonic diathermy Ultrasound and muscle stimulator Interferential current therapy Regulatory Class: Class II Product Code: IPF, GEJ, IMI, IMG, LIH

Dated: July 31, 2001 Received: August 23, 2001

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

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Page 2 - Mr. David Richards

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 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 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,

for Mailh n Melkerson

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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Page 1 of 3

510(k) Number (if known):

Device Name: RICH-MAR WINNER CM4

Indications For Use:

THERAPEUTIC ULTRASOUND

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

KO12848

• 1. 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)

for Mark N. Millican

(Optional Format 3-10-98)

eneral, Restorative ological Devices

510(k) Number K012848

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Page 2 of 3

510(k) Number (if known):

RICH-MAR WINNER CM4 Device Name:_

KO12848

Indications For Use:

MICROAMPERAGE PULSED CURRENT INDICATIONS FOR TREATMENT (Microcurrent)

Microcurrent output is indicated for the following conditions: I) Symptomatic relief of chronic, intractable pain. 2) Management of pain associated with post-traumatic or post-operative conditions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Milliken

. Restorative ogical Devices

K 012848 510(k) Number.

(Optional Format 3-10-98)

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Page 3 of 3

12848

510(k) Number (if known):

RICH-MAR WINNER CM4 Device Name:___

Indications For Use:

Quadpolar, Bipolar, Monophasic and Russian Waveforms

This device is indicated for the following conditions:

I) 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. Maniaming of mirgical stimulation of calf muscles to prevent venous thrombosis.

Powered muscle stimulators should only be used under medical supervision for I divertive therapy for the treatment of medical diseases and conditions.

(Quadpolar Interferential and Microamperage Pulsed Current)

I) Symptomatic relief of chronic, intractable pain,

2. Management of pain associated with post-traumatic or post-operative conditions.

(PLE/ NEEDEU)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mach N. Milhuner

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number

(Optional Format 3-10-98)

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).