DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE

K051261 · Dynatronics Corp. · ILY · Jul 25, 2005 · Physical Medicine

Device Facts

• Record ID: K051261
• Device Name: DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE
• Applicant: Dynatronics Corp.
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dynatron X3 device, including models Dynatron Xp and D405, provide topical heating via infrared therapy 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

System provides infrared (IR) therapy for topical heating. Components include system console (Dynatron X3) with control electronics/software, IR pad (Dynatron Xp), and hand-held IR probe (D405). Operated by clinicians within a therapy program. Device delivers IR energy to target areas to induce heat; intended to increase local blood circulation, relax muscles, and relieve minor pain/stiffness. Clinician monitors patient response to therapy. Benefits include temporary symptomatic relief of musculoskeletal conditions.

Clinical Evidence

No clinical data. Substantial equivalence based on technological similarity and adherence to performance standards for electronic products (21 CFR 1010).

Technological Characteristics

Infrared therapy system; console with control electronics and alpha-numeric displays; IR pad and hand-held IR probe applicators. Conforms to 21 CFR 1010 performance standards for electronic products. Software-controlled output.

Indications for Use

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

• Dynatron® Solaris™ D705 and accessory D880 IR Probe (K031329)

Submission Summary (Full Text)

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## Kosizel

## 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 Dyntron X3, Xp, D405); Infrared therapy.

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

## 2. PREDICATE DEVICE:

Dynatron® Solaris™ D705 and accessory D880 IR Probe Cleared under K031329 (October 22, 2003)

- 3. PERFORMANCE STANDARDS: The Dynatron Solaris Series of devices conform to the applicable requirements of 21 CFR sections 1010 (Performance Standards for Electronic Products: General).
- 4. DESCRIPTION: The Dynatron® Solaris™ model numbers X3, Dynatron Xp, and D405) provide infrared (IR) therapy.

Components:

System console, model Dynatron X3, containing software and control electronics with alpha-numeric displays.

Infrared pad, model Dynatron Xp, for administering IR therapy.

Hand-held infrared probe, model D405, for administering IR therapy.

Accessories such as power cord.

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Kosi261

- 5. INTENDED USE/INDICATIONS FOR USE: The Dynatron X3 device, including models Dynatron Xp and D405, provide topical heating via infrared therapy 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 X3, Dynatron Xp, and D405, offer topical heating for treatment of selected medical conditions. They share the same or similar basic characteristics, features and intended use as the predicate and, therefore, are substantially equivalent to the Dynatron D705 and the D880 infrared probe (applicable 'K' number listed above).
- 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 are verified/validated to applicable standards/guidance documents. The products, and accessories, are safe and effective, when used as indicated in specific applications under a clinician's supervision/therapy program.

Signed: Ronald J. Hald

Dated: May 13, 2005

Ronald J. Hatch, VP Operations/RA DYNATRONICS CORPORATION

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and health. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement around the left side of the logo. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 2005

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

Re: K051261

Trade/Device Name: Dynatron® X3, Dynatron® Xp IR Light Pad, D405 IR Light Probe Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: May 12, 2005 Received: May 16, 2005

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 (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. Ronald J. Hatch

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter natification. The FDA finding of substantial equivalence of your device to a legally premated 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 it you atence 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 other general mionmational 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,

Eun A

Miriam C. Provost, Ph.D Acting 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): ___K051261__________________________________________________________________________________________________________________________________________

Device Name: Dynatron® X3 Dynatron® Xp IR Light Pad D405 IR Light Probe

Indications for 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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

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Ko51261

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