THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000

K041200 · Migun Medical Instrument Co. , Ltd. · JFB · Jun 17, 2004 · Physical Medicine

Device Facts

• Record ID: K041200
• Device Name: THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
• Applicant: Migun Medical Instrument Co. , Ltd.
• Product Code: JFB · Physical Medicine
• Decision Date: Jun 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Migun Model HY-7000 Thermassage Energy Product is to provide therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for: - temporary relief of minor muscle and joint pain, and stiffness - the temporary relief of minor joint pain associated with arthritis - the temporary increase in local circulation where applied - relaxation of muscles

Device Story

The HY-7000 Thermassage Energy Product is a therapy table combining infrared heat and massage. It functions by delivering thermal energy via infrared lamps and mechanical massage to the user's body. Used in an over-the-counter (OTC) context, the device is operated by the user to alleviate minor muscle and joint pain, stiffness, and arthritis-related discomfort, while promoting muscle relaxation and local circulation. The device provides physical therapeutic stimulation; users experience heat and massage directly, which may improve comfort and mobility. No complex data processing or clinical decision support is involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Therapy table incorporating infrared lamps and mechanical massage components. Operates as a therapeutic massager and infrared heating device. Class II device under 21 CFR 890.5800, 890.5500, and 890.5660. Product codes: JFB, ILY, ISA.

Indications for Use

Indicated for individuals seeking temporary relief of minor muscle and joint pain, stiffness, and minor joint pain associated with arthritis; also indicated for muscle relaxation and temporary increase in local circulation.

Regulatory Classification

Identification

A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three stripes representing the department's mission to promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2004

Migun Medical Instrument Co. Ltd. C/o Edward A. Kroll Spectre Solutions, Inc. 5905 Fawn Lane Cleveland, Ohio 44141

Re: K041200

Trade/Device Name: HY7000 Thermassage Energy Product Trade/Device Name: 11117666 The S890.5800, 21 CFR §890.5500, 21 CFR §890.5660 Regulation Namber. 21 CPT 307011931521 therapy table, Infrared lamp, Therapeutic massager Regulatory Class: II Product Code: JFB, ILY, ISA Dated: April 30, 2004 Reccived: May 7, 2004

Dear Mr. Kroll:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) presidentially equivalent (for the indications referenced above and nave determined be a cases and see sparketed in interstate for use stated in the encrosule) to tegals actual date of the Medical Device American so to connineree prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been receassined in accessfired of a premarket approval application (PMA). alle Cosmetic Act (71ct) market the device, subject to the general controls provisions of the Act. The You may, merciole, market the act include requirements for annual registration, listing of gencial controls provisions of the rice, 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 If your device is classified (soc world) als. Existing major regulations affecting your device can Inay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Possial 2013
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 Ficase be advised that I Dri- 3 issuation virus complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of any I edelai statures and regalanceds and limited to: registration and listing (21 Comply with an the Act 31equirements, 01); good manufacturing practice requirements as set CFN Fart 807), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulantin (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maining of substantial equivalence of your device to a legally premarket notification: The Presification 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 desire specific arreliance at [phone]. Also, please note the regulation entitled, Comact the Office of Company of Company (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark Melkerson

Celia M. Witten, PhD, MD 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): _K041200_

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The intended use of the Migun Model HY-7000 Thermassage Energy Product is to The finchica use of the Migar Product n therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;

- temporary relief of minor muscle and joint pain, and stiffness o
- the temporary relief of minor joint pain associated with arthritis 0
- the temporary increase in local circulation where applied 0
- relaxation of muscles O

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

Center for Devices and Radiological Health / CDRH

Page **_ of _**
Mark A. Milken

Division of General, Restorative, and Neurological Devices

12041200

510(k) Number____