HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)

K050410 · Hwang Sun Enterprise Co., Ltd. · IMI · Jul 14, 2005 · Physical Medicine

Device Facts

• Record ID: K050410
• Device Name: HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)
• Applicant: Hwang Sun Enterprise Co., Ltd.
• Product Code: IMI · Physical Medicine
• Decision Date: Jul 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Device Story

HES® Ultrasonic Therapy Appliance generates deep heat within body tissues via ultrasonic energy. Used for temporary relief of minor pain, muscle spasms, and joint contractures. Operated by healthcare professionals in clinical settings. Device applies ultrasonic waves to target areas to induce therapeutic heating. Benefits include symptomatic relief of musculoskeletal conditions. Not indicated for malignancy treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic diathermy device; generates deep heat via ultrasonic energy; classified under 21 CFR 890.5300; Product Code IMI.

Indications for Use

Indicated for patients requiring deep tissue heating for temporary relief of minor pain, 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the circle is a stylized image of an eagle or other bird-like figure.

JUL 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hwang Sun Enterprise Co., LTD. c/o Sing-Hong Yeung Bellaire Industry & Trading Co. 11 Heather Court Middle Island, New York 11953

Re: K050410 R050410
Trade/Device Name: HES® Ultrasonic Therapy Appliance Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: II Product Code: IMI Dated: May 30, 2005 Received: June 3, 2005

Dear Sing-Hong Yeung:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQC ) premaincilly equivalent (for the indications
referenced above and have determined the device is substantially equivalent in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed president Device Amendments. for use stated in the enclosure) to tegally manced to health Device Amendments, or to
commerce prior to May 28, 1976, the enactives with the exceptions of the Federal Food. D commerce prior to May 28, 1976, the enactions of the Frosistions of the Federal Food, Drug, devices that have been reclassified in accordance with the provision of the Act. The Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject of the gentration listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mender requirements to the course of the successinst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mio existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affe may be subject to such additional controls: Listing may organ In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of reactal Regarations, This 2-7 ,
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 Please be advised that FDA s issualited of a substanter of the requirements of the Act
that FDA has made a determination that your device also Ferencies. You must that FDA has made a determination inalyou devices on other Federal agencies. You must
or any Federal statutes and regulations administed to: registration and listi or any Federal statutes and regulations and limited to: registration and listing (2)
comply with all the Act's requirements, including, but not be registration and listing (2 comply with all the Act s requirements, including, but not mining practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirem CFR Part 807); labeling (21 CFR Patl on (2) , good manara 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if appli forth in the quality systems (QS) regulation (21-51-143 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2-Sing-Hong Yeung

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin mailtoung your and equivalence of your device to a legally premarket notification: "The PDA mixing of castion 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 If you uesn't specific advice for your acc [phone]. Also, please note the regulation entitled, Comaci the Office of Compuner an (= + notification" (21CFR Part 807.97). You may obtain Misorallums by relevence to premainterior in the Act from the Division of Small other general information on Jour response at its toll-free number [phone] or Mallulacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Hyet Clurde
Miriam C. Provost, Ph.D.

am 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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HES® Ultrasonic Therapy Appliance 510K Notification

## INDICATIONS FOR USE

050410

510(k) Number (if known):

HES® Ultrasonic Therapy Appliance

Indications for Use:

Device Name:

A 22.0 4

The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Prescription Use ___X__ (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)

Styph Rurhm

(Division Division of General, Restorative, and Neurological Devices

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510(k) Number K050410