DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)

K031329 · Dynatronics Corp. · IMI · Oct 22, 2003 · Physical Medicine

Device Facts

• Record ID: K031329
• Device Name: DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
• Applicant: Dynatronics Corp.
• Product Code: IMI · Physical Medicine
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Dynatron Solaris Series of products, including Solaris 709, 708, 706, and 705, provide electrical stimulation, ultrasound and/or combination electrical stimulation and ultrasound, as well as infrared therapy. 1) Electrical Muscle stimulation therapy for: Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion 2) Transcutaneous electrical nerve stimulation and Interferential Current Therapy for: Symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain. 3) Ultrasound therapy for: Applying therapeutic deep heat within body tissues for the treatment of selected medical conditions such as: Relief of pain Muscle spasms Joint contractures 4) Infrared therapy to provide topical heating for: Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis

Device Story

Dynatron Solaris Series (models 705, 706, 708, 709) provides multi-modal physical therapy; includes electrical stimulation (Hi Volt, Russian, Biphasic, Direct Current, IFC, Premodulated, Microcurrent, Diadynamic), ultrasound, and optional infrared therapy (D880 probe). System comprises console with alpha-numeric display, software, control electronics, and various transducers/electrodes. Used in clinical settings by healthcare professionals to deliver therapeutic deep heat, muscle stimulation, or nerve stimulation. Output parameters controlled via console; clinician monitors patient response to adjust therapy. Benefits include pain relief, muscle spasm reduction, and improved circulation/range of motion.

Clinical Evidence

No clinical data. Bench testing only; device verified and validated under design/change control per 21 CFR Part 820 and applicable performance standards (21 CFR 1010, 1050).

Technological Characteristics

System console with alpha-numeric display, software, and control electronics. Modalities: electrical stimulation (various waveforms), ultrasound, infrared. Conforms to 21 CFR 1010 and 1050. Components: ultrasound transducer, infrared probe, electrotherapy multi-probe, patient cables, electrodes, gel, straps.

Indications for Use

Indicated for patients requiring electrical muscle stimulation (spasm relaxation, atrophy prevention, blood circulation, re-education, post-surgical calf stimulation, range of motion), TENS/IFC (chronic intractable pain, post-traumatic/post-surgical pain), ultrasound (deep heat for pain, spasms, contractures), or infrared therapy (topical heating for circulation, aches, stiffness, arthritis).

Regulatory Classification

Identification

An ultrasonic diathermy 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.

Predicate Devices

• Dynatron 950 (K950349)
• Dynatron 850 (K941461)
• Dynatron 650 (K950348)
• Dynatron 550 (K941577)
• MedX 1000 Series (K020017)

Submission Summary (Full Text)

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## OCT 2 2 2003

## SUMMARY OF SAFETY AND EFFECTIVENESS

DYNATRONICS CORPORATION SUBMITTED BY: 7030 Park Centre Drive Salt Lake City UT 84121 Phone: [phone]; Fax: [phone]

- 1. DEVICE NAME (Trade/common, and classification): Dynatron® Solaris™ Series (model numbers 709, 708, 706, and 705); Therapeutic Ultrasound, Interferential Current Therapy, Electrical Muscle Stimulator, Electrotherapy, Non-Invasive Electrical Nerve Stimulator, Ultrasound and Muscle Stimulator (and Accessories), and Infrared therapy.

| Classification: | Class II |
|-------------------|-----------------------------------------------------|
| Regulation Nos .: | 882.5890, 890.5300, 890.5850, 890.5860 and 890.5500 |
| Product Codes: | GZJ, IMI, IPF, IMG, LIH and ILY |

## 2. PREDICATE DEVICES:

- Solaris 709 Previously Dynatron 950, cleared under K950349 (Sep 13, 1995); Solaris 708 - Previously Dynatron 850, cleared under K941461 (Sep 01, 1995); Solaris 706 - Previously Dynatron 650, cleared under K950348 (Sep 13, 1995); Solaris 705 - Previously Dynatron 550, cleared under K941577 (Sep 01, 1995); Solaris D880 Infrared Probe -- SE to MedX 1000 Series, cleared under K020017 (July 12, 2002)
- PERFORMANCE STANDARDS: The Dynatron Solaris Series of devices conform to 3. the applicable requirements of 21 CFR sections 1010 (Performance Standards for Electronic Products: General) and 1050 (Performance Standards for Sonic, Infrasonic, and Ultrasonic Radiation-Emitting Products).
- 4. DESCRIPTION: The Dynatron® Solaris™ Series (Model numbers 709, 708, 706, and 705) provide electrical stimulation, ultrasound, and/or electrical stimulation and ultrasound, as well as optional infrared therapy.

Components:

System console, containing software and control electronics with alpha-numeric displays

Ultrasound transducer, infrared probe, and multi-probe for administering electrotherapy

Accessories such as patient cables, electrodes, transducer gel and elastic straps.

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- 5. INTENDED USE/INDICATIONS FOR USE: The Dynatron Solaris Series of products, including Solaris 709, 708, 706, and 705, provide electrical stimulation, ultrasound and/or combination electrical stimulation and ultrasound, as well as infrared therapy.
- 1) Electrical Muscle stimulation therapy for: Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion
- 2) Transcutaneous electrical nerve stimulation and Interferential Current Therapy for:

Symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.

- 3) Ultrasound therapy for:
Applying therapeutic deep heat within body tissues for the treatment of selected medical conditions such as:

- Relief of pain Muscle spasms Joint contractures
- 4) Infrared therapy to provide topical heating for:

Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles

Muscle spasms

Minor pain and stiffness associated with arthritis

The Intended Use/Indications For Use stated herein are consistent with the cleared indications for the predicate devices.

- 6. SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: The Dynatron Solaris 709, 708, 706, and 705, offer electrical stimulation, ultrasonic therapy and/or a combination of the two, and share the same or similar basic characteristics and the same general intended use in physical medicine, general and plastic surgery and neurology as the predicate devices. Therefore, the proposed Dynatron Solaris products are substantially equivalent to the Dynatron 950, 850, 650 and 550. The infrared therapy probe provides topical heating for treatment of selected medical conditions and shares the same or similar basic characteristics, features and intended use as the predicate and, therefore, is substantially equivalent to the MedX 1000 Series infrared probe (applicable 'K' numbers listed above).

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- 7. SAFETY AND EFFECTIVENESS: There are no substantive differences between the products defined in this 510(k) submission and the predicate devices. They are similar to the technologies that are currently used in other similar medical devices. They were developed and documented under Dynatronics' mature Quality Management System, under the Quality System Regulation, 21 CFR Part 820, under design/change control, and is verified/validated to applicable standards/guidance documents. The Solaris family of electrical stimulation, ultrasound, and/or combination products, and accessories, are safe and effective, when used as indicated in specific applications under a clinician's supervision/therapy program.
Signed: Ronald J. Hatch

Ronald J. Hatch, VP Operations/RA
DYNATRONICS CORPORATION

Dated: April 24, 2003

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

Ronald J. Hatch VP Operations/Regulatory Affairs Dynatronics, Corp. 7030 Park centre Dr. Salt Lake City, Utah 84121

Re: K031329

Trade/Device Name: Solaris Models 708 and 709 Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI

Trade/Device Name: Solaris Models 705, 706, 708 and 709 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF

Trade/Device Name: Solaris Models 705, 706, 708 and 709 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator v Regulatory Class: Class II Product Code: GZJ

Trade/Device Name: Solaris Models 705, 706, 708 and 709 Regulation Number: 21 CFR 882.5890 Regulation Name: Interferential Current Therapy Regulatory Class: Class II Product Code: LIH

Trade/Device Name: D880 Infrared Probe for use with Solaris Models 705, 706, 708 and 709 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Heat Lamp Regulatory Class: Class II Product Code: ILY

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Page 2 - Mr. Ronald J. Hatch

Dated: August 29, 2003 Received: September 4, 2003

## Dear Mr. Hatch:

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. 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

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Page 3 – Mr. Ronald J. Hatch

free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N. Milkerson

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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510(k) Number: K031329

Device Name: Dynatron® Solaris™ Series

Indications for Use:

Hi Volt, Russian, and Biphasic modes of stimulation are all forms of electrical muscle stimulation therapy available with the Solaris 709, 708, 706 & 705 and indicated for:

> Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion

The Direct Current mode of stimulation is also a form of electrical muscle stimulation therapy available with the Solaris 709, 708, 706 & 705 and indicated for:

Relaxation of muscle spasms

IFC, Premodulated, Microcurrent and Diadynamic modes of stimulation are all forms of transcutaneous electrical nerve stimulation (TENS) or Interferential Current Therapy (IFC) available with the Solaris 709, 708, 706 & 705 and indicated for:

> Symptomatic relief of chronic intractable pain and/or management of post traumatic or post-surgical pain

for Mark A. Milliner

[continued]

Division Sign-Off.
Division of General Restorative
and Neurological Devices

510(k) Number K031329

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Ultrasound therapy is available with the Solaris 709 & 708 and indicated for:

Applying therapeutic deep heat within body tissues for the treatment of selected medical conditions such as:

> Relief of pain , Muscle spasms Joint contractures

Infrared therapy is available as an optional accessory (D880) probe with the Solaris 709, 708, 706 & 705 and indicated to provide topical heating for:

> Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis

for Mark N. Millerson

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

510(k) Number K031329