SOLARIS D890 THERAPY PROBE

K040729 · Dynatronics Corp. · ILY · Jun 2, 2004 · Physical Medicine

Device Facts

• Record ID: K040729
• Device Name: SOLARIS D890 THERAPY PROBE
• Applicant: Dynatronics Corp.
• Product Code: ILY · Physical Medicine
• Decision Date: Jun 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Solaris D890 Therapy Probe is an infrared therapy accessory for Solaris Series combination devices. Device receives operational power and software control from base unit; probe contains on/off switch and software to drive infrared energy source. Used in clinical settings under clinician supervision/therapy program. Provides topical heating to treat muscle/joint pain, stiffness, spasms, and improve local circulation. Benefits patient through non-invasive thermal therapy.

Clinical Evidence

No clinical data. Device verification and validation performed under Dynatronics' Quality Management System and applicable standards/guidance documents.

Technological Characteristics

Infrared therapy probe; conforms to 21 CFR 1010, 1040.10, and 1040.11. Includes on/off switch and software to drive infrared energy source. Powered by Solaris Series base unit. Class II device.

Indications for Use

Indicated for patients requiring topical heating for temporary increase in local blood circulation, relief of minor muscle and joint aches, pains and stiffness, relaxation of muscles, relief of muscle spasms, and relief of minor pain and stiffness associated with arthritis.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• Solaris D880 Infrared Probe (K031329)

Submission Summary (Full Text)

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K040729

## SUMMARY OF SAFETY AND EFFECTIVENESS

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

- 1. DEVICE NAME (Trade/common, and classification): Solaris D890™ Therapy Probe.

| Classification: | Class II |
|------------------|----------|
| Regulation Nos.: | 890.5500 |
| Product Codes: | ILY |

- 2. PREDICATE DEVICES:
Solaris D880 Infrared Probe -- Cleared under K031329

- PERFORMANCE STANDARDS: The Solaris D890 conforms to the applicable 3. requirements of 21 CFR sections 1010 (Performance Standards for Electronic Products: General) and 21 CFR sections 1040.10 and 1040.11 (Performance Standards for Light-Emitting Products).
- 4. DESCRIPTION: The Solaris D890™ is an infrared therapy accessory probe for use with Solaris Series combination devices. The base Solaris devices provide the operational power and software. The D890 probe contains only an on/off switch and requisite software to drive the infrared energy source.
- 5. INTENDED USE/INDICATIONS FOR USE: The Solaris D890 provides infrared therapy for the following allowed claims:

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 identical to the cleared indications for the predicate device.

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- 6. SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: The Solaris D890 generates infrared therapy for treatment of selected medical conditions and shares the same or similar basic characteristics and the same intended use as the predicate device. Therefore, the proposed Solaris D890 is substantially equivalent to the Solaris D880 Infrared Probe, cleared under K031329
- 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 verified/validated to applicable standards/guidance documents. The Solaris D890 is 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: 3/9/04

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Image /page/2/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 in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 2 2004

Mr. Ronald J. Hatch Vice President Operations and Regulatory Affairs Dynatronics Corporation 7030 Park Centre Drive Salt Lake City, Utah 84121

Re: K040729

Trade/Device Name: Solaris™ D8907M Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: March 10, 2004 Received: March 22, 2004

Dear Mr. Hatch:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have a nowe 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 for use outstan to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 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). and Cosmeter For (10) in 10 (110) the general controls provisions of the Act. The r ou may, ateres provisions of the Act include requirements for annual registration, listing of general conable 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 thay or babyer to an a legulations, 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 docs not mean that FDA has made a determination that your device complies with other requirements of the Act that i Drederal statutes and regulations administered by other Federal agencies. You must or any I edetar baked and sequirements, 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 form in the quality of Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Ronald J. Hatch

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,

Miriam C. Provoost

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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## Indications for Use

510(k) Number (if known):

## K040729

Device Name:

Solaris™ D890™ Therapy Probe

Indications For Use:

Infrared therapy to provide topical heating for:

Temporary increase in 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

K Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

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510(k) Number_________________________________________________________________________________________________________________________________________________________________