SUN-RAIN ULTRASONIC THERAPY, SU-100

K024013 · Sun-Rain System Corp. · IMI · Oct 31, 2003 · Physical Medicine

Device Facts

• Record ID: K024013
• Device Name: SUN-RAIN ULTRASONIC THERAPY, SU-100
• Applicant: Sun-Rain System Corp.
• Product Code: IMI · Physical Medicine
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SU-100 generates 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.

Device Story

The SUN-RAIN Ultrasonic Therapy Model SU-100 is a therapeutic device designed to generate deep heat within body tissues. It operates by delivering ultrasonic energy to the target area to treat medical conditions including pain, muscle spasms, and joint contractures. The device is intended for prescription use by healthcare professionals in clinical settings. By inducing deep tissue heating, the device aims to provide therapeutic relief for the specified musculoskeletal conditions. It is not indicated for the treatment of malignancies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic diathermy device; Class II; Product Code IMI; 21 CFR 890.5300. Operates by generating deep heat within body tissues via ultrasonic energy.

Indications for Use

Indicated for patients requiring deep heat therapy for pain relief, muscle spasms, and joint contractures. Contraindicated for the treatment of malignancies.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 2003

SUN-RAIN System Corporation C/O Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K024013

Trade Name: SUN-RAIN Ultrasonic Therapy Model SU-100 Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI Dated: September 30, 2003 Received: October 10, 2003

Dear Dr. Jen:

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 - Dr. Ke-Min Jen

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

Sincerely yours,

Sincerely yours,

Mark N. Milken

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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## 4. INDICATIONS FOR USE STATEMENT

Applicant: SUN-RAIN SYSTEM CORPORATION

510(k) Number:

Device Name : _SUN-RAIN Ultrasonic Therapy, SU-100

## Indications for Use :

The SU-100 generates 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.

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

| Concurrence of CDRH Office of Device Evaluation (ODE) | <div> <span style="text-decoration: overline;">Mark A Wilkerson</span> </div> <div> <span>for</span> </div> |
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| (Division Sign-Off) | |
| Division of General, Jstorative and Neurological Devices | |
| 510(k) Number | K024013 |

| Prescription Use<br>Per 21 CFR 801.109 | <div> <span>✓</span> </div> | OR | Over-The-Counter<br>(Optional Format 1-2-96) |
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