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.

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. It contains 6 programs as similar to the predicate device; the output waveform is selectable pre-programming change among P1-P6 (in case of TG-body 10) The output strength is adjustable at 0-100mA via regulated voltage, with variable set time 5-60 minutes counting from starting session. 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.

AI/ML Overview

This is an interesting case where the provided document is a 510(k) summary for a powered muscle stimulator, not an AI/ML device. Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable.

However, I can extract the acceptance criteria and the methods used to demonstrate the device meets those criteria, primarily through comparison to a predicate device and adherence to industry standards for medical electrical equipment.

Here's an analysis based on the provided text, indicating where information is not applicable for a non-AI/ML medical device submission:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for "TG-BODY, MI&Body, S-Trainer" are implicitly defined by its substantial equivalence to the predicate device (K011880 Compex Sport Stimulator) and compliance with relevant safety and performance standards. The "performance" is demonstrated by showing that the new devices have comparable characteristics and meet the same standards.

Feature/Criterion (Implicit Acceptance Criteria: Equivalent to Predicate or Standard)	TG-BODY Performance	Mi&Body Performance	S-Trainer Performance	Predicate Device (K011880 Compex Sport)
Intended Use (Improve/facilitate muscle performance, not for medical conditions)	Same as Predicate	Same as Predicate	Same as Predicate	Stimulate healthy muscles
Technological Characteristics	Equivalent	Equivalent	Equivalent	-
Performance Properties	Equivalent	Equivalent	Equivalent	-
Power Source(s)	4.8V	3.7V	3.6V	7.2V
Method of Line Current Isolation	Transformers isolation	Transformers isolation	Transformers isolation	Transformers isolation
Patient Leakage Current - Normal Condition	2uA	2uA	2uA	2uA
Patient Leakage Current - Single Fault Condition	13uA	13uA	13uA	15uA
Number of Output Mode	1	1	1	1
Number of Output Channels	4	2	1	4
Synchronous or Alternating	Synchronous	Synchronous	Synchronous	Synchronous
Method of Channel Isolation	Galvanic	Galvanic	Galvanic	Galvanic
Regulated Current or Regulated Voltage?	500ohm RMS 26mA/13.0V, 2Kohm RMS 8.4mA/16.8V	500ohm RMS 15mA/7.5V, 2Kohm RMS 4.0mA/8.1V	500ohm RMS 15mA/7.5V, 2Kohm RMS 4.0mA/8.1V	500ohm RMS 21mA/11.8V, 2Kohm RMS 7mA/16V
Software/Firmware/Microprocessor Control	Yes	Yes	Yes	Yes
Automatic Overload 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
Indicator Display - Low Battery signal	Yes	Yes	Yes	Yes
Indicator Display - Voltage/Current Level	No	No	No	No
Timer Range (Minutes)	1 ~ 60	20 ~ 33	20 ~ 33	1 ~ 60
Compliance with Voluntary Standards	EN 60601-1, -1-1, -1-2, -2-10	EN 60601-1, -1-1, -1-2, -2-10	EN 60601-1, -1-1, -1-2, -2-10	EN 60601-1, -1-1, -1-2, -2-10
Compliance with 21 CFR 898?	Yes	Yes	Yes	Yes
Weight	360g	120g	70g	350g
Dimensions(WHD)	10616238.5(mm)	64.8103.626(mm)	515114(mm)	1429936(mm)
Housing Materials and Construction	ABS	ABS	ABS	Plastic case
Name of the output Mode	Square wave	Square wave	Square wave	Square wave
Clearly labeled amplitude and times axes	0~300	0~300	0~300	0~300
Identification of the amplitude baseline	-	-	-	-
List of all output parameter setting the load resistance	-	-	-	-
Waveform	Symmetrical biphasic square	Symmetrical biphasic square	Symmetrical biphasic square	Symmetrical biphasic square
Shape	Rectangular	Rectangular	Rectangular	Rectangular
Maximum output Voltage	100V peak	40V peak	40V peak	100V peak
Maximum output Current	26mA	14.4mA	13.3mA	21mA
Pulse Width	50 ~300	150-300	150~300	200 ~ 400
Frequency(Hz)	4 ~100	4~100	4~100	1 ~ 120
Beat Frequency(Hz)	-	-	-	-
For multiphasic waveforms only	-	-	-	-
Symmetrical phases	Yes	Yes	Yes	Yes
Phase duration(include units)	1 - 0.005	0.25 ~ 0.01	0.25 ~ 0.01	0.1 - 0.001
Net charge(mC per pulse)	0	0	0	0
Maximum Phase charge Density(uC)	36	24	24	18
Maximum Current Density(mA/cm2)	1.0432	0.20571	0.26473	9.6
Maximum Power Density(W/cm2)	0.06259	0.01059	0.00823	0.046
Burst mode	-	-	-	-
ON time(seconds)	10	10	10	-
OFF time(seconds)	10	10	10	-

2. Sample size used for the test set and the data provenance

This is not an AI/ML device and therefore does not have a "test set" in the context of machine learning. The "testing" involved bench testing to verify performance specifications and compliance with standards. The document does not specify the number of units tested.

Data Provenance: Not applicable for this type of device submission. The device is manufactured by Miga Medical Co., Ltd in Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device does not rely on interpretation of medical data or images requiring expert ground truth.

4. Adjudication method for the test set

Not applicable. There is no "test set" or human interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, nor does it involve human readers or image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

Not applicable. The "ground truth" for this device's performance is objective measurement against engineering specifications and compliance with recognized safety and performance standards (e.g., EN 60601 series).

8. The sample size for the training set

Not applicable. This is not an AI/ML device and therefore does not have a "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is based on:

Substantial Equivalence Comparison: A detailed comparison table ([1], [2]) demonstrates that the new devices (TG-BODY, MI&Body, S-Trainer) have equivalent intended use, technological characteristics, and performance properties to the predicate device (K011880 Compex Sport stimulator). While some specific values (like maximum current, voltage, and pulse width) differ, these differences are presented within the context of demonstrating overall equivalence for safety and effectiveness for the stated intended use.
Compliance with Consensus Standards: The devices meet consensus standards EN 60601-1 (general requirements for basic safety and essential performance), EN 60601-2-10 (particular requirements for nerve and muscle stimulators), EN 60601-1-2 (electromagnetic compatibility), and 21 CFR 898 (reports of adverse events). This is a critical component for demonstrating safety and performance.
Bench Testing: The summary explicitly states, "Bench testing was also conducted to demonstrate performance specifications." This indicates physical testing was performed on the devices to verify that their measured characteristics (e.g., output parameters, timing, safety features) matched their design specifications and were consistent with the comparison to the predicate device.

Conclusion:

The manufacturer concluded that the TG-BODY, MI&Body, and S-Trainer devices are safe and effective and substantially equivalent to the predicate device based on the information provided in the premarket notification, including the comparison table, adherence to recognized standards, and bench testing results. The FDA's letter (K122393) confirms this determination of substantial equivalence.

Summary

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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:

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:

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

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・

*performance properties

Comparison table is provided as below.

Features	New Device	New Device	New Device	PredicateDevice
510(K) Number	-	-	-	K011880
Device Name, Model	TG Body	Mi&Body	S-Trainer	Compex sportstimulatior
Manufacturer	Miga	Miga	Miga	Compex
Power Source(s)	4.8	3.7	3.6	7.2
- Method of LineCurrent Isolation:	Transformersisolation	Transformersisolation	Transformersisolation	Transformersisolation
- Patient LeakageCurrent:	-	-	-	-
- Normal Condition	2uA	2uA	2uA	2uA
- Single FaultCondition	13uA	13uA	13uA	15uA
Number of Output Mode	1	1	1	1
Number of OutputChannels	4	2	1	4
- Synchronous orAlternating	Synchronous	Synchronous	Synchronous	Synchronous
- Method of ChannelIsolation	galvanic	galvanic	galvanic	galvanic
Regulated Current orRegulated Voltage?	500ohm RMS26mA / RMS13.0V2Kohm RMS8.4mA / RMS16.8V	500ohm RMS15mA / RMS7.5V2Kohm RMS4.0mA / RMS8.1V	500ohm RMS15mA / RMS7.5V2Kohm RMS4.0mA / RMS8.1V	500ohm RMS21mA / RMS11.8V2Kohm RMS7mA / RMS 16V
Software/Firmware/Microprocessor Control	Yes	Yes	Yes	Yes
Automatic OverloadTrip	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 Batterysignal	Yes	Yes	Yes	Yes
- Voltage/Current Level	No	No	No	No
Timer Range(Minutes)	1 ~ 60	20 ~ 33	20 ~ 33	1 ~ 60

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K122393

・

	60601-1.60601-1-160601-1-2.60601-2-10	60601-1.60601-1-160601-1-2.60601-2-10	60601-1.60601-1-160601-1-2.60601-2-10	Page 3 of 460601-1.60601-1-160601-1-2.60601-2-10
Compliance WithVoluntary Standards
Compliance with 21CFR898?(Becomes MandatoryBeginning May 9,2000)	Yes	Yes	Yes	Yes
Weight	360g	120g	70g	350g
Dimensions(WHD)	10616238.5(mm)	64.8103.626(mm)	515114(mm)	1429936(mm)
Housing Materials andConstruction	ABS	ABS	ABS	Plastic case
the name of the outputMode	Square wave	Square wave	Square wave	Square wave
cleary labeledamplitude and timesaxes	0~300	0~300	0~300	0~300
identification of theamplitude baseline	-	-	-	-
a list of all outputparameter settingthe load resistance(inohms)	-	-	-	-
Waveform(e.g., pulsemonophasic,biphasic)	Symmetricalbiphasic square	Symmetricalbiphasic square	Symmetricalbiphasic square	Symmetricalbiphasic square
Shape(e.g.,rectangular, spike, rectified sinusoldal)	Rectangular	Rectangular	Rectangular	Rectangular
Maximum outputVoltage(specify units)	100V peak	40V peak	40V peak	100V peak
Maximum outputCurrent(specify units)	26mA	14.4mA	13.3mA	21mA
Pulse Width(specifyunits)	50 ~300	150-300	150~300	200 ~ 400
Frequency(Hz)	4 ~100	4~100	4~100	1 ~ 120
Beat Frequency(Hz)	-	-	-	-
For multiphasicwaveforms only	-	-	-	-
Symmetrical phases	Yes	Yes	Yes	Yes
Phase duration(includeunits)(state range, ifapplicable)(bothphases, ifasymmetrical)	1 - 0.005	0.25 ~ 0.01	0.25 ~ 0.01	0.1 - 0.001
net charge(m C perpulse)(if zero, statemethod of achievingzero net charge)	0	0	0	0
Maximum Phase chargeDensity(uC)	36	24	24	18
Maximum CurrentDensity(mA/cm2)	1.0432	0.20571	0.26473	9.6
Maximum PowerDensity(W/cm2)(usingsmallest electrodeconductive surfacearea)	0.06259	0.01059	0.00823	0.046
Burst mode(i.e., Pulsetrains)	-	-	-	-
a. pulses per burst	-	-	-	-
b. bursts per second	-	-	-	-
c. burstduration(seconds)	-	-	-	-
d. duty Cycle (line A *line B)	-	-	-	-
ON time(seconds)	10	10	10	-
OFF time(seconds)	10	10	10	-
Additional Features(ifapplicable)	-	-	-	-

. . . . . .

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

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K122393

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.

. '

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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

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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

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Indications for Use

510(k) Number (if known): K122393

TG-BODY, Mi&Body, S-Trainer Device Name:

Indications For Use:

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

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.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).