Pobling MIITY 2

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 20, 2017 HABALAN Med & Beauty Co., Ltd c/o Peter Chung President Plus Global 300 Atwood Pittsburgh, Pennsylvania 15213 Re: K163550 Trade/Device Name: Pobling MIITY 2 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: December 7, 2017 Received: December 13, 2017 Dear Peter Chung: 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 {1}------------------------------------------------ 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 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. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Vivek J. Pinto -S 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K163550 Device Name Pobling MIITY 2 Indications for Use (Describe) The Pobling MITY 2 is intended for facial stimulation and is indicated for over-the counter cosmetic use. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for HABALAN, with the words "Different Insight" underneath. The logo is in a bold, sans-serif font. The letters are all capitalized and connected to each other. The words "Different Insight" are in a smaller, sans-serif font. # 510(k) Summary Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92 ### 1. Submitter's Information - 1) Name : HABALAN Med & Beauty Co., Ltd - 2) Address : 907, 219, Gasandigital 1-ro, Geumcheon-gu, Seoul, KOREA - 3) Contact person : Mr. Peter Chung 300 Atwood Street Pittsburgh, PA 15213, USA Tel : 412-512-8802 - 4) Date prepared : December, 05, 2016 #### 2. Device Information - 1) Trade/Proprietary Name : Pobling MIITY 2 - 2) Common Name : Facial Toning Device - 3) Classification Name : Transcutaneous Electrical Nerve Stimulator - 4) Device Class : Class II - 5) Product Code : NFO - 6) Regulation Number : 21 CFR 882.5890 #### 3. Predicate Device - 1) Carol Cole Company, NuFACE® Plus, K103472 - 2) Nu Skin Enterprises, Inc., NuSkin Facial Spa, K122711 #### 4. Intended Use The Pobling MIITY 2 is intended for facial stimulation. #### 5. Indication for Use The Pobling MIITY 2 is indicated for over-the counter cosmetic use. #### 6. Device Description Pobling MIITY 2 is a facial toning device and it is composed of main unit and adaptor. The micro-current is delivered to healthy facial skin through head of main unit to stimulate the face. The device is a battery-powered and hand-held device. There have heating and cooling function by pressing the button additionally. #### 7 Comparison with Predicate Device The MITY 2 is identical with predicate devices for intended use and indications for use. It is {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a stylized wordmark for "HABALAN" in a bold, sans-serif font. The letters are interconnected, creating a continuous, flowing design. The color of the text is black, and the background is white, providing a high contrast. #### Different Insight used as same technological principle with predicate devices to accomplish its intended use. all are hand-held, battery powered device and the there is no new questions of safety and/or effectiveness. The determination of substantial equivalence for the MITY2 is based on an assessment of non-clinical performance. This assessment included a comparison of the MIITY2 to that of predicate. The output performance testing included: - Maximum output voltaget - Maximum output current | Features | Subject Device | Predicate Device | | Justification | |----------------------------------------|----------------------------------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------|---------------| | | MIITY 2 | NuFACE® Plus | NuSkin Facial Spa | — | | 510(k) Number | To be assigned | K103472 | K122711 | — | | Regulation Number | 21 CFR § 882.5890 | | | Same | | Regulation Name | Transcutaneous Electrical Nerve Stimulator | | | Same | | Regulatory Class | Class II | | | Same | | Product Code | NFO | | | Same | | Intended Use | Stimulate the face | | | Same | | Indication for Use | Over-the-Counter Cosmetic Use | | | Same | | Power Source | Battery operated | | | Same | | Number output<br>channels | 1 | | | Same | | Automatic shut off | Yes | | | Same | | Indicator Display | | | | | | 1) ON / OFF? | Yes | | | Same | | 2) Low-Battery? | Yes | | | Same | | On Time (seconds) | Constant | | | Same | | Off Time (seconds) | None | | | Same | | Compliance with<br>Voluntary Standards | IEC 60601-1 / IEC 60601-1-2 / IEC 60601-1-11 | | | Same | | Mode | Two | One | One to Five | Similar | | Wave form | Direct | Pulsed Monophasic | Direct Current | Same | | Maximum Output<br>Voltage | @500Ω<br>Mode1: 174mV<br>Mode2: 174mV | @500Ω<br>137mV | @500Ω<br>Mode1: 188mV(214mV)<br>Mode2: 189mV(225mV)<br>Mode3: 185mV(220mV)<br>Mode4: 184mV(212mV)<br>Mode5: 184mV(213mV) | Similar | | | @2kΩ<br>Mode1: 710mV<br>Mode2: 710mV | @2kΩ<br>769mV | @2kΩ<br>Mode1: 722mV(1527mV)<br>Mode2: 746mV(812mV)<br>Mode3: 735mV(815mV)<br>Mode4: 740mV(802mV)<br>Mode5: 741mV(801mV) | Similar | | | Subject Device | Predicate Device | | Justification | | Features | MIITY 2 | NuFACE® Plus | NuSkin Facial Spa | – | | Maximum Output | @10kΩ | @10kΩ | @10kΩ | Similar | | Voltage | Model: 3200mV | 3.82V | Model: 2.626V(2.978V) | | | | Mode2: 3200mV | | Mode2: 3.787V(4.011V) | | | | | | Mode3: 3.747V(4.014V) | | | | | | Mode4: 3.503V(3.980V) | | | | | | Mode5: 3.729V(3.980V) | | | Maximum Output | @500Ω | @500Ω | @500Ω | Similar | | Current | Model: 350uA | 274uA | Model: 376uA(427uA) | | | | Mode2: 350uA | | Mode2: 379uA(449uA) | | | | | | Mode3: 371uA(440uA) | | | | | | Mode4: 368uA(424uA) | | | | | | Mode5: 369uA(427uA) | | | | @2kΩ | @2kΩ | @2kΩ | Similar | | | Model: 360uA | 387uA | Model: 361uA(763uA) | | | | Mode2: 360uA | | Mode2: 373uA(406uA) | | | | | | Mode3: 367uA(407uA) | | | | | | Mode4: 370uA(401uA) | | | | | | Mode5: 370uA(400uA) | | | | @10kΩ | @10kΩ | @10kΩ | Similar | | | Model: 320uA | 383uA | Model: 362uA(398uA) | | | | Mode2: 320uA | | Mode2: 379uA(401uA) | | | | | | Mode3: 375uA(401uA) | | | | | | Mode4: 350uA(398uA) | | | | | | Mode5: 373uA(398uA) | | | Heating and Cooling | Model: Heating | | | Minor | | | (Temp. 41℃±3℃) | | | function | | | Mode2: Cooling | | | | | | (Temp. 10℃±3℃) | | | | | Weight | 115g | 9oz | 120g (approx. 4oz) | – | | | | | Facial Spa with Large | | | Dimensions | 150 x 500<br>unit : mm | 3" x 5.25" x 1.25" | 143 x 31.2 x 67.5 mm | | | | | | (5.6" x 1.2" x 2.7") | | | | | | Facial Spa with Small | | | | | | 136 x 31.2 x 67.5 mm | | | | | | (5.4" x 1.2" x 2.7") | | | Housing material | ABS | Thermo Plastic | ABS, Chrome plate | - | | and construction | | | ABS, rubber (elastomer) | | ## TABLE : Comparison of MIITY 2 with predicate devices {5}------------------------------------------------ The heating and cooling are not a major function to be used as accomplished its intended use as stimulator. That are minor for distinguishing the mode. And also conducted the performance data. Therefore, all the difference don't affect the safety and effectiveness which is concluded after all the required testing, So no safety and effectiveness issues relating to the MIITY2 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for HABALAN. The logo is black and consists of the word "HABALAN" in a stylized font. Below the logo, the words "Different Insight" are written in a smaller, sans-serif font. # 8. Performance Data The following performance data were provided in support of the substantial equivalence determination 1) Electrical Safety and Electromagnetic compatibility(EMC) Electrical safety and EMC testing were conducted on MITY2, it comples with the IEC 60601-1:2005 +am1:2002 for safety and the IEC 60601-1-2:2007 standard for EMC. - 2) Biocompatibility Testing The biocompatibility evaluation for the contact part with healthy facial skin of MIITY2 was conducted in accordance with the ISO 10993, Cytotoxicity, Skin Sensitization and Skin Irritation testing, it was considered contacting part and duration (Tissue contacting, Duration of less than 24hours) - 4) Technical characteristic testing To show the technical characteristic testing about Transcutaneous Electrical Nerve Stimulator, the test was conducted in our testing method. - 5) Thermal Safety testing The device have the heating and cooling function with stimulation. To verify the heating and cooling properties, we performed the testing in our testing method. - 6) Clinical data Not applicable # 9. Conclusion The fundamental technology to be accomplished its intended use in view of technological and operational characteristics between MITY2 and predicate device is same. Non-clinical performance as documented support the safety and effectiveness are similar to the predicate device. In other words, the MIITY2 is substantially equivalent to the predicate devices.