CHOYANG THERMAL MASSAGER

K111941 · Choyang Medical Instrument Co., Ltd. · JFB · May 25, 2012 · Physical Medicine

Device Facts

• Record ID: K111941
• Device Name: CHOYANG THERMAL MASSAGER
• Applicant: Choyang Medical Instrument Co., Ltd.
• Product Code: JFB · Physical Medicine
• Decision Date: May 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the CHOYANG Thermal Massager (Model: CY-7000) is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.

Device Story

The CHOYANG Thermal Massager (Model: CY-7000) is an electrically powered, motorized physical therapy table. It features two independent carriages, each equipped with five infrared lights. The device is operated by a user in a supine position. During operation, the carriages traverse the length of the table from the lower to the upper torso, applying heat and light pressure to the user's back. The device offers both 'Auto' and 'Semi-Auto' modes, controlled via a rubber-pad remote. It is designed to provide muscle relaxation therapy. The device is intended for use in a clinical or home setting. By delivering localized heat and mechanical massage, the device aims to provide therapeutic benefits to the patient's muscles.

Clinical Evidence

Bench testing only. Compliance with EN 60601-1-2 standards was verified by SGS Testing Korea. No clinical trials were conducted.

Technological Characteristics

Electrically powered, motorized physical therapy table. Features two independent carriages with five infrared lights each. Jade massage rollers. Rated input: 120V AC, 50-60Hz, 250W. Ambient temperature range: 40-70°C. Safe working load: 150kg. Type BF applied part. Remote control interface. Software-controlled operation modes (Auto/Semi-Auto).

Indications for Use

Indicated for patients requiring muscle relaxation therapy via heat and soothing massage. No specific age or gender restrictions provided.

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.

Predicate Devices

• HY7000 Thermassage Energy Product (K041200)
• CERAGEM-RH1 Automatic Thermal Massager (K062476)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a logo with the word "CHOYANG" in a stylized font. The word is positioned to the right of a curved, swooping shape that resembles a crescent or an arc. The logo is set against a white background, and the text and shape are in black.

# MAY 2 5 2012

Exhibit 5 510(k) Summary

CHOYANG Thermal Massager (Model: CY-7000)

- 1. Submitter and US Official Correspondent

| Submitter: | Choyang Medical Instrument Co., Ltd. |
|------------|--------------------------------------------------------------------------------|
| Address: | 66-3 Yogwang-ri, Chubu-myeon, Geumsan-gun<br>Chungcheongnam-do, 312-943, Korea |
| | Tel: [phone]~3<br>Fax: [phone] |
| | Contact: Jung Hyun, Quality Assurance Manager<br>Email: [e-mail] |

| US Official Correspondent: | Shin Kuk Yoo, Consultant |
|----------------------------|---------------------------|
| Telephone No.: | 714-313-7442 |
| Fax No.: | 8 01-303-7455 |
| Email: | [e-mail] |

### 2. Establishment Registration Number

The firm will be registered and listed prior to distribution of medical device in United States.

### 3. Device Information

| Proprietary/Trade Name: | CHOYANG Thermal Massager (Model: CY-7000) |
|--------------------------|-------------------------------------------------------------|
| Common/Usual Name: | Multi-function physical therapy table, Therapeutic massager |
| Classification Name: | Table, Physical therapy, Multi-function |
| Product Code: | JFB |
| Subsequent Product Code: | ISA |
| Device Class: | Class II per regulation 21 CFR 890.5880, 21 CFR 890.5660 |

### 4. New or modification

:

This notification is for a new device for the USA market.

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### 5. Equivalent Legally Marketed Device

| Predicate #1 | |
|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Migun Medical Instrument Co., Ltd. |
| Device Name: | HY7000 Thermassage Energy Product |
| 510(k) Number: | K041200 (Decision Date - June 17, 2004) |
| Classification: | Table, Physical Therapy, Multi Function<br>JFB (Classification Product Code)<br>Class II per regulation 21 CFR 890.5880 |

## Predicate #2

| Manufacturer: | CERAGEM Co., Ltd. |
|-----------------|-----------------------------------------|
| Device Name: | CERAGEM-RH1 Automatic Thermal Massager |
| 510(k) Number: | K062476 (Decision Date - Oct. 31, 2006) |
| Classification: | Table, Physical Therapy, Multi Function |
| | JFB (Classification Product Code) |
| | Class II per regulation 21 CFR 890.5880 |

### ଚ. Description of the Device

The CHOYANG Thermal Massager (Model: CY-7000) is an electrically powe red, motorized multi-functional physical therapy table. It is intended function and use is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. The massage function is delivered by way of two independent carriages. Each carriage has five infrared lights. During use, these carriages traverse from lower torso to upper torso and apply light pressure as well as heat to the supine user.

### 7. Indications for use

The intended use of the CHOYANG Thermal Massager (Model: CY-7000) is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.

### 8. Safety, EMC and Performance Data

The compliance of the CHOYANG Thermal Massager (Model: CY-7000) has been satisfied with the applicable requirements of the EN 60601-1-2. The tests have been performed by SGS Testing Korea.

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### 9. Safety and Effectiveness, comparison to Predicate

The results of bench and clinical evaluation indicate that the new device is as safe and effective as the predicate devices.

### 10. Substantial Equivalence Chart

.

| No | Item | CHOYANG Thermal<br>Massager | HY7000 Thermassage<br>Energy Product | Ceragem-RH1 Automatic<br>Massager |
|----|----------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| 1 | 510K Number | None | K041200 | K062476 |
| 2 | Manufacturer | Choyang Medical<br>Instrument Co., Ltd. | Migun Medical<br>Instrument Co., Ltd. | CERAGEM Co., Ltd. |
| 3 | Regulation Number | CFR 890.5880, | CFR 890.5880, | CFR 890.5880, |
| 4 | Product code | JFB, ISA | JFB, ISA, ILY | JFB, ISA, ILY |
| 5 | Classification | Class II<br>(21CFR 890.5880) | Class II<br>(21CFR 890.5880) | Class II<br>(21CFR 890.5880) |
| 6 | Rated input voltage | 120V a.c | 120V a.c | 120V a.c |
| 7 | Supply Frequency | 50-60Hz | 50Hz | 60Hz |
| 8 | Rated input power | 250W | 269W | 290W |
| 9 | Degree of protection | Type BF applied part | Type BF applied part | Type BF applied part |
| 10 | Ambient temperature | 40~70℃ | 40~70℃ | 30~60℃ |
| 11 | Weight | 64Kg | 74Kg | 87Kg |
| 12 | Safe working load | Max. 150Kg | Max. 150Kg | Max. 140Kg |
| 13 | Massage roller | Jade | Geranium Cerramic | Jade |
| 14 | Mode Set-Up | Auto Mode<br>Semi-Auto Mode | Auto Mode<br>Semi-Auto Mode | Auto Mode<br>Semi-Auto Mode |
| 15 | Remote Buttons | Rubber Pad Type | Rubber Pad Type | Rubber Pad Type |
| 16 | Operating time | 36min | 34min | 40min |
| 17 | Intended Use | The intended use of the<br>CHOYANG Thermal<br>Massager is to provide<br>patients with muscle | The intended use of the device is to provide patients<br>with muscle relaxation therapy by delivering heat and<br>soothing massage. Additionally, the infrared lamps<br>provide topical heating for; | |
| | relaxation | therapy by | | - temporary relief of minor muscle and joint pain and |
| | delivering | heat and | | stiffness |
| | soothing massage. | | | - the temporary relief of minor joint pain associated |
| | | | | with arthritis |
| | | | | - the temporary increase in local circulation where |
| | | | | applied |
| | | | | - relaxation of muscle |

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### 11. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided the above comparison table, the Choyang Medical Instrument Co., Ltd. concludes that the CHOYANG Thermal Massager (Model: CY-7000) is safe and effective and substantially equivalent to the predicate devices as described above.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes that resemble human figures or elements of a design. The logo is presented in black and white.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 25 2012

Choyang Medical Instrument Co., Ltd. % LSK BioPartners, Inc. Mr. Shin Kuk Yoo 8 East Broadway, Suite 611 Salt Lake City, Utah 84111

Re: K11941

Trade/Device Name: Choyang Thermal Massager (Model: CY-7000) Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-function physical therapy table Regulatory Class: Class II Product Code: JFB Dated: May 15, 2012 Received: May 17, 2012

Dear Mr. Shin Kuk Yoo:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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# Page 2 - Mr. Shin Kuk Yoo

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Euil Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Exhibit 4 Indications for Use

510(k) number (if known):
K111994

Device Name: CHOYANG Thermal Massager (Model: CY-7000)

Indications for Use:

The intended use of the CHOYANG Thermal Massager (Model: CY-7000) is to provide patients with muscle relaxation therapy by delivering heat and soothing massage.

Prescription Use

(Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vernon H. Clark

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111941