TG-BODY MI&BODY S-TRAINER

{0}------------------------------------------------ # DEC 1 0 2013 ### 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. Submitter Information: Miga Medical Co., Ltd 925, Pyongsan-Dong, Yangsan-Si Kyongsangnam-Do, Korea Contact Person: Yang Ho Dong Onbix Corporation #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, Seoul, 135-768, Korea Tel: *82-2-5663360 / Fax: *82-2-62803360 Email: onbix@naver.com Date Summary Prepared: Dec 09, 2013 ### Device Name: | Trade Name(s): | TG-BODY, MI&Body, S-Trainer | |----------------------|-----------------------------| | Classification Name: | Powered Muscle Stimulator | | Panel: | Physical Medicine | | Product Code: | NGX | ### Predicate Device Information: K011880 Compex sport stimulator, Compex #### Device Description: The MIGA Co.,Ltd OTC EMS System . model TG-Body. S-Trainer and Mi&Body are intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance; it is not intended as a therapy for any medical condition. Basically the model TG-body, powered by 4.8V, S-Trainer, powered by 3.6V and Mi&Body, powered by 3.7V are muscle stimulation devices and identical to the predicate device -K011880 (Compex Sport) with the following features: It is a portable, battery operated neuromuscular electronic stimulation system. [1] It contains 6 programs as similar to the predicate device; the output waveform is (2) selectable pre-programming change among P1-P6 (in case of TG-body 10) [3] The output strength is adjustable at 0-100mA via regulated voltage, with variable set time 5-60 minutes counting from starting session. [4] The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication. #### Intended Use: TG-BODY, MI&Body, S-Trainer are intended to stimulate healthy muscles in order to improve or facilitate muscle performance and not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. #### Comparison to Predicate Device(s): These devices are equivalent to the predicate devices in its intended use and technological characteristics, including: > *indications for use *technological characteristics {1}------------------------------------------------ ・ # *performance properties Comparison table is provided as below. | Features | New Device | New Device | New Device | Predicate<br>Device | |----------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------| | 510(K) Number | - | - | - | K011880 | | Device Name, Model | TG Body | Mi&Body | S-Trainer | Compex sport<br>stimulatior | | Manufacturer | Miga | Miga | Miga | Compex | | Power Source(s) | 4.8 | 3.7 | 3.6 | 7.2 | | - Method of Line<br>Current Isolation: | Transformers<br>isolation | Transformers<br>isolation | Transformers<br>isolation | Transformers<br>isolation | | - Patient Leakage<br>Current: | - | - | - | - | | - Normal Condition | 2uA | 2uA | 2uA | 2uA | | - Single Fault<br>Condition | 13uA | 13uA | 13uA | 15uA | | Number of Output Mode | 1 | 1 | 1 | 1 | | Number of Output<br>Channels | 4 | 2 | 1 | 4 | | - Synchronous or<br>Alternating | Synchronous | Synchronous | Synchronous | Synchronous | | - Method of Channel<br>Isolation | galvanic | galvanic | galvanic | galvanic | | Regulated Current or<br>Regulated Voltage? | 500ohm RMS<br>26mA / RMS<br>13.0V<br>2Kohm RMS<br>8.4mA / RMS<br>16.8V | 500ohm RMS<br>15mA / RMS<br>7.5V<br>2Kohm RMS<br>4.0mA / RMS<br>8.1V | 500ohm RMS<br>15mA / RMS<br>7.5V<br>2Kohm RMS<br>4.0mA / RMS<br>8.1V | 500ohm RMS<br>21mA / RMS<br>11.8V<br>2Kohm RMS<br>7mA / RMS 16V | | Software/Firmware/Micr<br>oprocessor Control | Yes | Yes | Yes | Yes | | Automatic Overload<br>Trip | Yes | Yes | Yes | Yes | | Automatic No-Load Trip | Yes | Yes | Yes | Yes | | Automatic Shut Off | Yes | Yes | Yes | Yes | | Patient Override Control | Yes | Yes | Yes | Yes | | Indicator Display | | | | | | - On/Off Status | Yes | Yes | Yes | Yes | | - Low Battery<br>signal | Yes | Yes | Yes | Yes | | - Voltage/Current Level | No | No | No | No | | Timer Range(Minutes) | 1 ~ 60 | 20 ~ 33 | 20 ~ 33 | 1 ~ 60 | 2 {2}------------------------------------------------ K122393 . : · , . ・ | | 60601-1.60601-1-1<br>60601-1-<br>2.60601-2-10 | 60601-<br>1.60601-1-1<br>60601-1-<br>2.60601-2-10 | 60601-<br>1.60601-1-1<br>60601-1-<br>2.60601-2-10 | Page 3 of 4<br>60601-<br>1.60601-1-1<br>60601-1-<br>2.60601-2-10 | |-----------------------------------------------------------------------------------------------------|-----------------------------------------------|---------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------| | Compliance With<br>Voluntary Standards | | | | | | Compliance with 21<br>CFR898?<br>(Becomes Mandatory<br>Beginning May 9,2000) | Yes | Yes | Yes | Yes | | Weight | 360g | 120g | 70g | 350g | | Dimensions(W*H*D) | 106*162*38.5(m<br>m) | 64.8*103.6*26(m<br>m) | 51*51*14(mm) | 142*99*36(mm) | | Housing Materials and<br>Construction | ABS | ABS | ABS | Plastic case | | the name of the output<br>Mode | Square wave | Square wave | Square wave | Square wave | | cleary labeled<br>amplitude and times<br>axes | 0~300 | 0~300 | 0~300 | 0~300 | | identification of the<br>amplitude baseline | - | - | - | - | | a list of all output<br>parameter setting<br>the load resistance(in<br>ohms) | - | - | - | - | | Waveform(e.g., pulse<br>monophasic,biphasic) | Symmetrical<br>biphasic square | Symmetrical<br>biphasic square | Symmetrical<br>biphasic square | Symmetrical<br>biphasic square | | Shape(e.g.,<br>rectangular, spike, rectifi<br>ed sinusoldal) | Rectangular | Rectangular | Rectangular | Rectangular | | Maximum output<br>Voltage(specify units) | 100V peak | 40V peak | 40V peak | 100V peak | | Maximum output<br>Current(specify units) | 26mA | 14.4mA | 13.3mA | 21mA | | Pulse Width(specify<br>units) | 50 ~300 | 150-300 | 150~300 | 200 ~ 400 | | Frequency(Hz) | 4 ~100 | 4~100 | 4~100 | 1 ~ 120 | | Beat Frequency(Hz) | - | - | - | - | | For multiphasic<br>waveforms only | - | - | - | - | | Symmetrical phases | Yes | Yes | Yes | Yes | | Phase duration(include<br>units)(state range, if<br>applicable)(both<br>phases, if<br>asymmetrical) | 1 - 0.005 | 0.25 ~ 0.01 | 0.25 ~ 0.01 | 0.1 - 0.001 | | net charge(m C per<br>pulse)(if zero, state<br>method of achieving<br>zero net charge) | 0 | 0 | 0 | 0 | | Maximum Phase charge<br>Density(uC) | 36 | 24 | 24 | 18 | | Maximum Current<br>Density(mA/cm2) | 1.0432 | 0.20571 | 0.26473 | 9.6 | | Maximum Power<br>Density(W/cm2)(using<br>smallest electrode<br>conductive surface<br>area) | 0.06259 | 0.01059 | 0.00823 | 0.046 | | Burst mode(i.e., Pulse<br>trains) | - | - | - | - | | a. pulses per burst | - | - | - | - | | b. bursts per second | - | - | - | - | | c. burst<br>duration(seconds) | - | - | - | - | | d. duty Cycle (line A *<br>line B) | - | - | - | - | | ON time(seconds) | 10 | 10 | 10 | - | | OFF time(seconds) | 10 | 10 | 10 | - | | Additional Features(if<br>applicable) | - | - | - | - | : . . . . . . · : : : . 3 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : {3}------------------------------------------------ ### K122393 4 ### Performance Test Data and Conclusions: These devices meet consensus standards EN 60601-1, EN 60601-2-10, EN 60601-1-2. Bench testing was also conducted to demonstrate performance specifications. Based on the information provided in this premarket notification Miga Medical Co., Ltd concludes that the TG-BODY, MI&Body, S-Trainer are safe and effective and substantially equivalent to predicate device as described herein. . ' {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized eagle-like symbol with three curved lines representing the body and wings. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ### December 10, 2013 Miga Medical Co., Ltd c/o Yang Ho Dong Onbix Corporation 821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, 135-768 Seoul South Korea Re: K122393 Trade/Device Name: TG-Body, MI&Body, and S-Trainer Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: November 20, 2013 Received: November 27, 2013 Dear Yang Ho Dong: 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. However, we remind you 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {5}------------------------------------------------ Page 2 - Yang Ho Dong 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Victor Krauthamer -A Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure . In rant 800); fabening (2 {6}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K122393 TG-BODY, Mi&Body, S-Trainer Device Name: Indications For Use: TG-BODY, MI&Body, S-Trainer are intended to stimulate healthy muscles in order to improve or facilitate muscle performance and not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. Prescription Use (Part 21 CFR 801 Subpart D) 13 4, 188 (21 CAN 1280 000), moonan as are . . . . . . . . . . . . AND/OR Over-The-Counter Use _ x (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) # Victor K 2013.12 Page 1 of ____________________________________________________________________________________________________________________________________________________________________ s rate on transmill (21 Cark fall . .