N5-1

K153054 · Nuga Medical Co., Ltd. · JFB · Feb 5, 2016 · Physical Medicine

Device Facts

• Record ID: K153054
• Device Name: N5-1
• Applicant: Nuga Medical Co., Ltd.
• Product Code: JFB · Physical Medicine
• Decision Date: Feb 5, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for; -Temporary relief of minor muscle and joint pain, and stiffness. - Temporary relief of minor joint pain associated with arthritis. - The temporary increase in local circulation where applied. - Relaxation of muscle.

Device Story

N5-1 is an electric multi-function physical therapy device for muscle relaxation and topical heating. System components include a main assembly (mat) with 7 internal heating roller-type ceramics, a 5-ball projector, and a remote control. Device operates by delivering heat and mechanical massage to the patient's body (cervical to lumbar region). Used in home or clinic settings; operated by the patient or a caregiver. The remote control allows users to select manual or automatic massage modes and adjust temperature (40-60°C). Heat is generated via Tourmanium ceramic elements. Output provides thermal and mechanical stimulation to muscles and joints, intended to alleviate pain and stiffness and improve local circulation. Benefits include non-invasive muscle relaxation and symptomatic pain relief.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (AAMI ES60601-1) and electromagnetic compatibility (IEC 60601-1-2) testing. Software verification and validation performed.

Technological Characteristics

Multi-function physical therapy table. Materials: Tourmanium ceramic heating elements. Energy source: Electric. Temperature range: 40-60°C. Max load: 170 kg. Components: Main assembly, 5-ball projector, remote control. Software: Moderate level of concern. Standards: AAMI ES60601-1, IEC 60601-1-2.

Indications for Use

Indicated for patients requiring muscle relaxation therapy, temporary relief of minor muscle/joint pain, stiffness, arthritis-related joint pain, and increased 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.

Predicate Devices

• NM-7000 (K111329)

Submission Summary (Full Text)

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

February 5, 2016

Nuga Medical Co., Ltd Jong Soo Lee Vice President 185. Jiraeul-ro. Jijeong-myeon Wonju, Gangwon-do 220-821 Republic of Korea

Re: K153054 Trade/Device Name: N5-1 Regulation Number: 21 CFR 890.5880 Regulation Name: Multi-Function Physical Therapy Table Regulatory Class: Class II Product Code: JFB, ILY, ISA Dated: January 4, 2016 Received: January 5, 2016

Dear Jong Soo Lee:

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K153054

Device Name NS-I

Indications for Use (Describe)

The intended use of the N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;

-Temporary relief of minor muscle and joint pain, and stiffness.

- Temporary relief of minor joint pain associated with arthritis.
- The temporary increase in local circulation where applied.

- Relaxation of muscle.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

[As required by 21 CFR 807.92]

#### Date Prepared [21 CFR 807.92(a)(a)] 1.

February 4, 2016

#### Submitter's Information [21 CFR 807.92(a)(1)] 2.

| Name of Sponsor: | NUGA MEDICAL Co., Ltd. |
|-----------------------|----------------------------------------------------------------|
| Address: | 185, Jiraeul-ro, Jijeong-myeon, Wonju-si,<br>Gangwon-do, Korea |
| Contact Name: | Jong Soo Lee/Vice President |
| Telephone No.: | [phone] |
| Fax No.: | [phone] |
| Email Address: | [e-mail] |
| Registration Number: | 300200626518 |
| Name of Manufacturer: | Same as Sponsor |
| Address: | Same as Sponsor |

#### Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.

| Trade Name: | N5-1 |
|-------------|------|
|-------------|------|

- Common Name: Personal Heating Therapeutic Device ●
- Classification:

| Classification Name | 1. Multi-Function Physical Therapy Table<br>2. Massager, Therapeutic, Electric<br>3. Lamp, Infrared, Therapeutic Heating |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Classification Panel | Physical Medicine |
| Classification Regulation | 21 CFR 890.5880, 21 CFR 890.5660 and<br>21 CFR 890.5500 |
| Product Code | 1. JFB<br>2. ISA<br>3. ILY |
| Device Class | II |

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Image /page/4/Picture/0 description: The image shows the logo for NUGA BEST. The logo consists of a stylized graphic of three figures in pink on the left, followed by the text "NUGA BEST" in blue. The "BEST" portion of the text has a trademark symbol next to it.

# 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[

The identified predicate device within this submission is shown as follow;

- 510(k) Number: K111329
- Applicant: NUGA MEDICAL Co., Ltd. ●
- Common Name: Personal Heating Therapeutic Device ●
- Device Name: NM-7000

There are no significant differences between the N5-1 and the predicate device that would adversely affect the use of the product. It is substantially equivalent to both device in design, operational principles, functions and technological characteristics.

#### 5. Description of the Device [21 CFR 807.92(a)(4)]

The N5-1 Personal Heating Therapeutic Device is the electric multi-function physical energy device. Its use is to provide muscle relaxing therapy to patients via a thermal function and massage and this device consist of the following components:

- (1) Main assembly
- (2) 5-Ball Projector
- (3) Remote Control
- (4) Accessories

Inside the main assembly, 7 internal heating roller type ceramics, which can massage from the cervical vertebra to the lumbar, have been installed.

#### 6. Intended Use [21 CFR 807.92(a)(5)]

The intended use of the N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, it provides topical heating for;

- -Temporary relief of minor muscle and joint pain, and stiffness.
- -Temporary relief of minor joint pain associated with arthritis.
- -The temporary increase in local circulation where applied.
- -Relaxation of muscle.

# General Information

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Image /page/5/Picture/0 description: The image shows the logo for Nuga Best. The logo consists of a pink circular graphic with white figures inside, followed by the text "NUGA BEST" in blue. The word "BEST" has a trademark symbol next to it.

# 7. Technological Characteristics [21 CFR 807.92(a)(6)]

The N5-1 is based on a technical feature comparison, the subject device was found to be similar to predicate device with regard to design, function, and technical characteristics.

| | Proposed Device | Predicate Device |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | Not known | K111329 |
| Common name | Personal Heating<br>Therapeutic Device | Personal Heating<br>Therapeutic Device |
| Model | N5-1 | NM-7000 |
| Manufacturer | NUGA MEDICAL Co., Ltd. | NUGA MEDICAL Co., Ltd. |
| Intended Use | The intended use of the N5-<br>1 is to provide patients<br>with muscle relaxation<br>therapy by delivering heat<br>and soothing massage.<br>Additionally, it provides<br>topical heating for;<br>-Temporary relief of minor<br>muscle and joint pain, and<br>stiffness.<br>- Temporary relief of minor<br>joint pain associated with<br>arthritis.<br>- The temporary increase in<br>local circulation where<br>applied.<br>- Relaxation of muscle. | The intended use of the<br>NM-7000 is to provide<br>patients with muscle<br>relaxation therapy by<br>delivering heat and<br>soothing massage.<br>Additionally, it provides<br>topical heating for;<br>- Temporary relief of minor<br>muscle and joint pain, and<br>stiffness.<br>- Temporary relief of minor<br>joint pain associated with<br>arthritis.<br>- The temporary increase in<br>local circulation where<br>applied.<br>- Relaxation of muscle. |
| Emission Source | Tourmanium ceramic | Tourmanium ceramic |

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Image /page/6/Picture/0 description: The image contains the logo for NUGA BEST. The logo consists of a circular graphic on the left and the text "NUGA BEST" on the right. The circular graphic is pink and appears to depict three stylized figures with their arms raised. The text "NUGA BEST" is in a bold, sans-serif font and is colored blue. A small trademark symbol is located to the upper right of the word BEST.

| Design | | | |
|-------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------|
| Component | Main assembly (Mat),<br>Auxiliary Heating Part,<br>5-ball Projector,<br>Remote controller | Mat,<br>Auxiliary mat,<br>5-ball Projector,<br>9-ball Projector,<br>Remote controller,<br>Leg heater | |
| Accessory | Outside cover,<br>Projector cover,<br>User manual | Outside cover,<br>Projector cover,<br>User manual | |
| Material | Internal<br>Projector | Ceramic | Ceramic |
| | External<br>Projector | Ceramic | Ceramic |
| Technical Specification | | | |
| Temperature | | 40 - 60°C (104 - 140°F) | 40 - 60°C (104 - 140°F) |
| Mode set-up | | Manual Mode and Auto<br>Mode 1/2 | Manual Mode 1/2 and Auto<br>Mode 1/2/3/4 |
| Safe<br>Working Lode | 170 kg | | 170 kg |

The key differences between both devices are (1) the music player function on the remote controller, (2) the size of the main assembly, (3) the list of components (with or without the 9-ball projector and the leg heater), and (4) Mode set-up, and which do not raise any new safety and effectiveness issues.

# Non-Clinical Test Summary:

- 1) Electrical Safety, Electromagnetic Compatibility and Performance:
The N5-1 complies with the electrical safety and electromagnetic compatibility requirements established by the standards AAMI ES60601-1 and IEC 60601-1-2.

- · Testing to confirm compliance with the safety requirements of standard AAMI ES60601-1
- · Testing to confirm compliance with EMC requirements of standard IEC 60601-1-2

# General Information

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Image /page/7/Picture/0 description: The image shows the logo for NUGA BEST. The logo consists of a stylized image of three people holding hands in a circle on the left, and the words "NUGA BEST" in blue on the right. The logo is simple and modern, and it is likely used to represent a company or organization that is focused on health and wellness.

- 2) Software Validation:
The N5-1 contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated.

Software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005;

- 3) Clinical Test Summary:
No clinical studies were considered necessary and performed.

- 4) Biocompatibility
The N5-1 does not contain any parts which be contacted with the body of patient directly. Therefore the biocompatibility test has not been performed.

#### Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] 8.

When compared to the predicate device (K111329), the N5-1 and the predicate are similar, with respect to indications for use and design, function, and technical characteristics.

#### Conclusion [21 CFR 807.92(b)(3)] 9.

In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification NUGA MEDICAL Co., Ltd., concludes that the N5-1 is substantially equivalent to predicate device as described herein.