AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE

• K Number: K032941
• Device Name: AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
• Manufacturer: RICH-MAR CORP.
• Date Cleared: 2003-10-22 ( 30 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. - Prevention or retardation of disuse atrophy. 2. - 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: - 1. Relief of pain - 2. Muscle spasms - 3. Joint contractures But NOT for the treatment of malignancies

Device Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

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 context of medical devices. The description focuses on the physical modalities and their therapeutic applications.

Therapeutic

Yes
The "Intended Use / Indications for Use" section explicitly states therapeutic applications such as "Relaxation of muscle spasms," "Relief of pain," and "Increasing local blood circulation," which are all therapeutic in nature.

Diagnostic

No
The provided text describes indications for treatment, such as muscle relaxation, pain relief, and increasing blood circulation, which are therapeutic applications rather than diagnostic ones.

SaMD (Software as a Medical Device)

No

The intended use describes muscle stimulator and ultrasound devices, which are hardware-based medical devices. There is no mention of software as the primary or sole component.

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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
• Device Description: The provided text describes a muscle stimulator and ultrasound device. These devices apply energy to the body externally for therapeutic purposes.
• Intended Use: The listed indications for use involve treating conditions within the body (muscle spasms, pain, etc.) through external application of stimulation and heat. There is no mention of analyzing samples taken from the body.

Therefore, the function and intended use of this device clearly fall outside the scope of In Vitro Diagnostics.

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.
• 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

Product codes

IPF, IMI, IMG, GZJ, LIH

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032941 Trade/Device Name: AutoSound 7.6 Regulation Number: 21 CFR 890.5850, 21 CFR 890.5300, 21 CFR 890.5860, 21 CFR 882.5890 Regulation Name: Powered muscle stimulator, Ultrasonic diathermy, Ultrasound and muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: IPF, IMI, IMG, GZJ, LIH Dated: September 12, 2003 Received: September 25, 2003

OCT 2 2 2003

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 (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.

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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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.

Sincerely yours,

Mark A. Millenson

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

Enclosure

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510(k) Number (if known):

Device Name: Rich-Mar AutoSound 7.6

Indications For Use:

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

K1332941

• 1. Relaxation of muscle spasms.
• Prevention or retardation of disuse atrophy. 2.
• 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:

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

But NOT for the treatment of malignancies

for Mark A. Milliken

Division of General, Restorative and Neurological Devi

510(k) Number_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)