(116 days)
Not Found
No
The document describes a programmable muscle stimulator controlled by a microprocessor and software, but there is no mention of AI or ML capabilities.
No.
The intended use is purely cosmetic (strengthening, toning, and firming of the abdomen region) and explicitly states it is "not designed for injured or ailing muscles," which would be a characteristic of a therapeutic device.
No
The device is described as an "electrical muscle stimulator intended to improve or facilitate muscle performance," specifically for "strengthening, toning and firming of the abdomen region." Its purpose is to deliver electrical current to muscles, not to diagnose medical conditions or identify diseases.
No
The device description explicitly states it consists of a stimulator, electrodes, and support belts, which are hardware components. While it mentions software control, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The GEMORE GEM-TONE Abdominal Training System is an electrical muscle stimulator that applies electrical current to the abdomen region to strengthen, tone, and firm muscles. It does not analyze biological samples.
- Intended Use: The intended use is for muscle conditioning, not for diagnosing or detecting any medical condition.
The device description and intended use clearly indicate that it is a physical therapy/fitness device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GEMORE GEM-TONE Abdominal Training System/model GEM-TONE 310PE/320PE/340PE/340PE/350PE are the electrical muscle stimulator intended for the following indication for use: - Strengthening, toning and firming of the abdomen region. The GEMORE GEM-TONE Abdominal Training System and its stimulation programs are not designed for injured or ailing muscles, and use on such muscles is contraindication.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
The GEM-TONE Abdominal Training System model GEM-TONE 310PE/ 320PE /330PE /340PE / 350PE is battery-operated programmable muscle stimulator intended to improve or facilitate muscle performance by applying an electrical current to electrodes, which is attached on abdomen region. GEM-TONE Abdominal Training System model GEM-TONE 310PE / 320PE /330PE /340PE /350PE, consists mainly of three parts: the stimulator , electrodes, and support belts fitting for special parts of body. The stimulator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the specified region, so as to transmit this stimulus current to the region of abdomen for the following intended purposes: - Strengthening, toning and firming of the abdomen region. The GEMORE GEM-TONE Abdominal Training System and its stimulation programs are not designed for injured or ailing muscles, and use on such muscles is contraindication. To adequately locate the stimulation on the intended treatment area, the following support belt is provided together with the stimulator: - The abdomen belt, which is capable of connecting to the both two output channels of stimulator. The stimulation mode for GEM-TONE Abdominal Training System includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen region
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)
Not Found
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
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K091833
-
- Submitter's Identifications: Gemore Technology Co., Ltd. 11FL., NO. 29-5, Sec. 2. Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan
OCT 1 6 2009
- Submitter's Identifications: Gemore Technology Co., Ltd. 11FL., NO. 29-5, Sec. 2. Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan
Contact: Mr.Boden S.P. Lai President & Official Correspondent
Date of Summary Preparation: Auqust 30,2009.
-
- Name of the Device:
| Trade name: | GEN-TONE Abdominal Training system; model GEM-TONE
310PE/320PE/330PE/340PE/350PE |
|----------------------|-------------------------------------------------------------------------------------|
| Common name: | Powered Muscle Stimulator |
| Classification name: | Stimulator, Muscle, Powered |
| Product Code: | NGX |
3. Information of the 510(k) Cleared Device (Predicate Device):
For this 510(k) submission, we compared our models to the following FDA cleared OTC devices:
- K010335: Slendertone Flex, made by Bio-Medical Research Ltd.
4. Device Description:
The GEM-TONE Abdominal Training System model GEM-TONE 310PE/ 320PE /330PE /340PE / 350PE is battery-operated programmable muscle stimulator intended to improve or facilitate muscle performance by applying an electrical current to electrodes, which is attached on abdomen region.
GEM-TONE Abdominal Training System model GEM-TONE 310PE / 320PE /330PE /340PE /350PE, consists mainly of three parts: the stimulator , electrodes, and support belts fitting for special parts of body. The stimulator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the specified region, so as to transmit this stimulus current to the region of abdomen for the following intended purposes:
- Strengthening, toning and firming of the abdomen region.
The GEMORE GEM-TONE Abdominal Training System and its stimulation programs are not designed for injured or ailing muscles, and use on such muscles is contraindication.
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Gemore Technology Co., Ltd.
To adequately locate the stimulation on the intended treatment area, the following support belt is provided together with the stimulator:
- · The abdomen belt, which is capable of connecting to the both two output channels of stimulator.
The stimulation mode for GEM-TONE Abdominal Training System includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.
5. Intended Use:
Basically the indication for use is defined clearly as the description of the following statement:
The GEMORE GEM-TONE Abdominal Training System/model GEM-TONE 310PE/320PE/330PE/340PE/350PE are the electrical muscle stimulator intended for the following indication for use:
-
. Strengthening, toning and firming of the abdomen region.
The GEMORE GEM-TONE Abdominal Training System and its stimulation programs are not designed for injured or ailing muscles, and use on such muscles is contraindication. -
Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as 6. follows:
Compliance to applicable voluntary standards includes ANSI/AAMI. NS4-1985, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
7. Conclusions
The GEM-TONE Abdominal Training System, model GEM-TONE 310PE / 320PE /330PE /340PE /350PE, has the same intended use and technological characteristics as the cleared device of Slendertone Flex (K010335) . Moreover, verification tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted model could maintain the same safety and effectiveness as that of cleared device.
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device. Therefore, the GEM-TONE Abdominal Training System, model GEM-TONE 310PE / 320PE /340PE /350PE, is substantial equivalent to the chosen predicate model.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing service to the nation. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Gemore Technology Co., Ltd. % Mr. Boden Lai 11FL. No. 29-5. Sec. 2. Chung Cheng E. Road, Tan Shui, Taipei Hsien China (Taiwan) 251
OCT 1 6 2009
Re: K091833
Trade/Device Name: GEM-TONE Abdominal Training System, Models 310PE, 320PE, 330PE, 340PE, and 350PE
Regulation Name: 21 CFR 890.5850
Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX Dated: September 5, 2009 Received: September 8, 2009
Dear Mr. Lai:
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.
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 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.
3
Page 2 - Mr. Boden Lai
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/McdicalDevices/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,
Mark N. Melkerson
Mark N. Melkerson Director
Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known):
Device Name: GEM-TONE Abdominal Training System / Model: GEM-TONE 310PE/320PE/330PE/340PE/350PE.
Indications For Use:
The GEMORE GEM-TONE Abdominal Training System/model GEM-TONE 310PE/320PE/340PE/340PE/350PE are the electrical muscle stimulator intended for the following indication for use:
- Strengthening, toning and firming of the abdomen region. t
The GEMORE GEM-TONE Abdominal Training System and its stimulation programs are not designed for injured or ailing muscles, and use on such muscles is contraindication.
Prescription Use (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use V (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Yousuf M. Al-Otaibi FOR M. MELKERSON
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K0918 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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