SONIC-STIM

K063135 · Naimco, Inc. · IMG · Feb 5, 2007 · Physical Medicine

Device Facts

• Record ID: K063135
• Device Name: SONIC-STIM
• Applicant: Naimco, Inc.
• Product Code: IMG · Physical Medicine
• Decision Date: Feb 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For Russian, and High Volt - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increase local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis For interferential and premodulated interferential - Symptomatic relief of chronic, intractable pain - Management of pain associated with post-traumatic or post-operative conditions For Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: Pain Relief - Reduction of muscle spasms - Joint contractures For TENS and EMS Symptomatic relief and management of chronic intractable pain - Adjunctive treatment in the management of post surgical and post traumatic acute pain condition

Device Story

Sonic-Stim is a multi-modality therapeutic device combining ultrasound and electrical muscle stimulation (Russian, High Volt, Interferential, Premodulated, TENS, EMS). Device configurations include 2-channel or 4-channel stimulators, with or without ultrasound capability. Operated by clinicians in a therapeutic setting, the device delivers electrical pulses via electrodes or deep heat via ultrasound transducer. Ultrasound coupling gel is used for heat transmission. Output parameters are adjusted by the clinician to manage pain, reduce muscle spasms, or facilitate muscle rehabilitation. The device provides therapeutic benefits through physical stimulation and thermal energy, aiding in post-surgical recovery and chronic pain management.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Multi-channel electrical stimulator and ultrasound device. Includes electrodes (K050469) and coupling gel (K012522). Modalities: Russian, High Volt, Interferential, Premodulated, TENS, EMS, and Ultrasound. Class II device per 21 CFR 890.5860 and 21 CFR 882.5890.

Indications for Use

Indicated for patients requiring muscle spasm relaxation, prevention of disuse atrophy, increased local blood circulation, muscle re-education, range of motion maintenance, or prevention of venous thrombosis. Also indicated for symptomatic relief of chronic intractable pain, post-traumatic/post-operative pain, and therapeutic deep heat for sub-chronic/chronic conditions including joint contractures.

Regulatory Classification

Identification

An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.

Predicate Devices

• Chattanooga Group Vectra GENiSYS (K031077)
• Biomedical Life Science, QUADSTAR II (K010749)

Submission Summary (Full Text)

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K063135
Pag 1:2

5 2007

## www.naimco.com

Plant: 888-549-4945 Fax: [phone]

4120 South Creek F Chattanooga, TN 374

### 510(k) Summary

Submitter's Information:

Julie Creasman, Regulatory Affairs Manager NAlmco, Inc. 4120 South Creek Road Chattanooga, TN 37406

Ultrasound and Powered Muscle Stimulator

K031077 (Chattanooga Group Vectra GENiSYS) K010749 (Biomedical Life Science, QUADSTAR II)

890.5860 and 21 CFR 882.5890)

Ultrasound and Powered Muscle Stimulator (per 21 CFR

Phone: [phone] Fax: [phone]

Date of Preparation:

Sonic-Stim

February 1, 2007

Common Name:

Proprietary Name:

Classification Name:

Predicate Device:

Description of Device:

Ultrasound and Muscle Stimulator. Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator. Available as 2 channel stimulator, 4 channel stimulator, ultrasound, 2 channel stimulator with ultrasound, and 4 channel stimulator with ultrasound.

Units are supplied with electrodes listed in 510(K) K050469, typically 2 x 2 inch.

Units are supplied with a bottle of ultrasound coupling gel listed in 510(K) K012522, or similar gels already in the market.

Intended Use:

### For Russian, and High Volt

- Relaxation of muscle spasms ●
- Prevention or retardation of disuse atrophy .
- . Increase local blood circulation
- Muscle re-education .
- Maintaining or increasing range of motion ●

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- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
### For interferential and premodulated interferential

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

#### Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: Pain Relief . Reduction of muscle spasms . Joint contractures . For TENS and EMS Symptomatic relief and management of chronic . intractable pain . Adjunctive treatment in the management of post surgical and post traumatic acute pain condition Technological Comparison: Summary of the technological characteristics compare to the predicate devices. Labeling Comparison: Labeling of the device compares to that of predicate devices.

Non-clinical Testing: Not Applicable

.

For Ultrasound

- Clinical Testing: Not Applicable
- Conclusions: As provided in the Comparison and Standards sections, the Sonic-Stim device models have similar characteristics and are equivalent to models of the VECTRA GENISYS and the QUADSTAR II.

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Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

North American Industrial Manufacturing Company % Julie Creasman Regulatory Affairs Manager 4120 South Creek Road Chattanooga, TN 37406

್ನೆ ಮತ್ತು 5 2007

Re: K063135

Trade/Device Name: Sonic-Stim Regulation Number: 21 CFR 890.5860, 21 CFR 882.5890 Regulation Name: Ultrasound and muscle stimulator Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: IMG, GZJ, IPF, GZI. Dated: December 19, 2006 Received: December 28, 2006

Dear Ms. Creasman:

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

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Page 2 - Ms. Julie Creasman

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 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/industry/support/index.html.

Sincerely yo

full

Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Image /page/4/Picture/1 description: The image shows a logo for "North American Industrial manufacturing company". The logo features the letters "NA" in a large, bold font, with a globe-like image above the letters. To the right of the letters "NA" are the letters "mco" in a smaller font.

4120 South Creek Chattanooga, TN 37 K063135

Device Name: Sonic-Stim

# For Russian, and High Volt

- Relaxation of muscle spasms ●
- Prevention or retardation of disuse atrophy ●
- Increase local blood circulation .
- Muscle re-education .
- Maintaining or increasing range of motion ●
- Maintaining of incroacing range in the cles to prevent venous thrombosis

## For interferential and premodulated interferential

- Symptomatic relief of chronic, intractable pain .
- Oymptomatio roller of essociated with post-traumatic or post-operative . conditions

### For Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

- Pain Relief .
- Reduction of muscle spasms .
- Joint contractures �

### For TENS and EMS

- Symptomatic relief and management of chronic intractable pain .
- Adjunctive treatment in the management of post surgical and post . traumatic acute pain condition

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <b>X</b> AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) |
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (QDE)<br>Page 1 of ______ | (Division Sign-Off)<br>Division of General, Restorative,<br>and Neurological Devices |
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| 510(k) Number | 1063136 |