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

K032941 · Rich-Mar Corp. · IPF · Oct 22, 2003 · Physical Medicine

Device Facts

• Record ID: K032941
• Device Name: AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
• Applicant: Rich-Mar Corp.
• Product Code: IPF · Physical Medicine
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

AutoSound 7.6 is a multi-modality therapeutic device combining muscle stimulation and ultrasound. It delivers Quadpolar, Bipolar, Monophasic, Russian, Interferential, and Microamperage Pulsed Current waveforms for neuromuscular stimulation and pain management. Ultrasound component provides therapeutic deep heat. Used in clinical settings by healthcare professionals. Device outputs electrical stimulation and ultrasonic energy to patient tissues. Clinical benefit includes pain relief, improved muscle function, and increased local circulation. Operation involves clinician selection of waveform and parameters based on patient condition.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Multi-modality system combining powered muscle stimulator and ultrasonic diathermy. Waveforms: Quadpolar, Bipolar, Monophasic, Russian, Interferential, and Microamperage Pulsed Current. Energy: Electrical stimulation and ultrasonic energy. Form factor: Clinical console unit. Connectivity: Not specified. Sterilization: Not applicable.

Indications for Use

Indicated for patients requiring muscle stimulation for spasm relaxation, atrophy prevention, circulation improvement, muscle re-education, range of motion maintenance, or post-surgical venous thrombosis prevention. Also indicated for pain management (chronic intractable, post-traumatic, post-operative) using interferential/microcurrent waveforms, and therapeutic deep heat for pain, spasms, and contractures. Contraindicated for malignancies.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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_

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Concurrence of CDRH, Office of Device Evaluation (ODE)