(490 days)
Not Found
No
The device description focuses on standard electrical muscle stimulation technology with pre-programmed settings and adjustable parameters. There is no mention of AI, ML, or any adaptive or learning capabilities.
No
The "Intended Use / Indications for Use" section explicitly states that the device is "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind."
No
The device description explicitly states that it is "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind" and "it is not intended as a therapy for any medical condition." Diagnostic devices are used to identify or determine the nature of a disease or condition, which is contrary to the stated purpose of this device.
No
The device description explicitly states that the devices are "portable, battery operated neuromuscular electronic stimulation system" and mentions power sources (4.8V, 3.6V, 3.7V), output strength (0-100mA), and an LCD display. These are all hardware components, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The provided text clearly describes a device that uses electrical stimulation to target and improve muscle performance in healthy individuals. It works externally on the body, not by analyzing samples taken from the body.
- Intended Use: The intended use explicitly states it's for stimulating healthy muscles and is "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind." This further reinforces that it's not for diagnostic purposes.
The device described is a neuromuscular electronic stimulation system, which is a different category of medical device than an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
Device |
|----------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------|
| 510(K) Number | - | - | - | K011880 |
| Device Name, Model | TG Body | Mi&Body | S-Trainer | Compex sport
stimulatior |
| Manufacturer | Miga | Miga | Miga | Compex |
| Power Source(s) | 4.8 | 3.7 | 3.6 | 7.2 |
| - Method of Line
Current Isolation: | Transformers
isolation | Transformers
isolation | Transformers
isolation | Transformers
isolation |
| - Patient Leakage
Current: | - | - | - | - |
| - Normal Condition | 2uA | 2uA | 2uA | 2uA |
| - 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 / RMS
13.0V
2Kohm RMS
8.4mA / RMS
16.8V | 500ohm RMS
15mA / RMS
7.5V
2Kohm RMS
4.0mA / RMS
8.1V | 500ohm RMS
15mA / RMS
7.5V
2Kohm RMS
4.0mA / RMS
8.1V | 500ohm RMS
21mA / RMS
11.8V
2Kohm RMS
7mA / RMS 16V |
| Software/Firmware/Micr
oprocessor 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 |
| - Low Battery
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
.
:
·
,
.
・
| | 60601-1.60601-1-1
60601-1-
2.60601-2-10 | 60601-
1.60601-1-1
60601-1-
2.60601-2-10 | 60601-
1.60601-1-1
60601-1-
2.60601-2-10 | Page 3 of 4
60601-
1.60601-1-1
60601-1-
2.60601-2-10 |
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------|---------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------|
| Compliance With
Voluntary Standards | | | | |
| Compliance with 21
CFR898?
(Becomes Mandatory
Beginning May 9,2000) | Yes | Yes | Yes | Yes |
| Weight | 360g | 120g | 70g | 350g |
| Dimensions(WHD) | 10616238.5(m
m) | 64.8103.626(m
m) | 515114(mm) | 1429936(mm) |
| Housing Materials and
Construction | ABS | ABS | ABS | Plastic case |
| the name of the output
Mode | Square wave | Square wave | Square wave | Square wave |
| cleary labeled
amplitude and times
axes | 0300 | 0300 | 0300 | 0300 |
| identification of the
amplitude baseline | - | - | - | - |
| a list of all output
parameter setting
the load resistance(in
ohms) | - | - | - | - |
| Waveform(e.g., pulse
monophasic,biphasic) | Symmetrical
biphasic square | Symmetrical
biphasic square | Symmetrical
biphasic square | Symmetrical
biphasic square |
| Shape(e.g.,
rectangular, spike, rectifi
ed sinusoldal) | Rectangular | Rectangular | Rectangular | Rectangular |
| Maximum output
Voltage(specify units) | 100V peak | 40V peak | 40V peak | 100V peak |
| Maximum output
Current(specify units) | 26mA | 14.4mA | 13.3mA | 21mA |
| Pulse Width(specify
units) | 50 300 | 150-300 | 150300 | 200 ~ 400 |
| Frequency(Hz) | 4 100 | 4100 | 4~100 | 1 ~ 120 |
| Beat Frequency(Hz) | - | - | - | - |
| For multiphasic
waveforms only | - | - | - | - |
| Symmetrical phases | Yes | Yes | Yes | Yes |
| Phase duration(include
units)(state range, if
applicable)(both
phases, if
asymmetrical) | 1 - 0.005 | 0.25 ~ 0.01 | 0.25 ~ 0.01 | 0.1 - 0.001 |
| net charge(m C per
pulse)(if zero, state
method of achieving
zero net charge) | 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)(using
smallest electrode
conductive surface
area) | 0.06259 | 0.01059 | 0.00823 | 0.046 |
| Burst mode(i.e., Pulse
trains) | - | - | - | - |
| a. pulses per burst | - | - | - | - |
| b. bursts per second | - | - | - | - |
| c. burst
duration(seconds) | - | - | - | - |
| d. duty Cycle (line A *
line B) | - | - | - | - |
| ON time(seconds) | 10 | 10 | 10 | - |
| OFF time(seconds) | 10 | 10 | 10 | - |
| Additional Features(if
applicable) | - | - | - | - |
:
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:
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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
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.