(309 days)
Not Found
No
The device description and performance studies focus on electrical stimulation parameters and software verification, with no mention of AI or ML technologies.
No
The "Intended Use / Indications for Use" section explicitly states, "Not intended for use in any therapy or for the treatment of any medical conditions or diseases."
No
Explanation: The "Intended Use / Indications for Use" section explicitly states "Not intended for use in any therapy or for the treatment of any medical conditions or diseases," and its purpose is for "improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles," which are not diagnostic functions.
No
The device description explicitly states it is comprised of a main device for signal generation, four belts for fixation, and series electrodes, all of which are hardware components. It also mentions being battery operated and having buttons for control.
Based on the provided information, the SM9065 Fitness Belt is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for improving muscle tone, strengthening, and developing firmer muscles. This is a physical effect on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description clearly states it's a muscle stimulation system that sends electrical current to targeted muscle groups. This is a physical intervention, not a diagnostic process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
- Contraindications and Limitations: The contraindications and limitations relate to physical conditions (injured or impaired muscles) and explicitly state it's "Not intended for use in any therapy or for the treatment of any medical conditions or diseases." This further reinforces its non-diagnostic nature.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The SM9065 Fitness Belt does not fit this definition.
N/A
Intended Use / Indications for Use
The SM9065 Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.
-
The big belt is intended for use on the muscles in abdomen.
-
The small belt is intended for use on the muscles in arms and thighs areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
SM9065 Fitness Belt is a two channels battery operated muscle stimulation system to achieve the purpose of exercise and relaxation. It is comprised of a main device for signal generation, four belts for fixation, and series electrodes.
The big belt is intended for use on muscles in abdomen. The two small belts are intended for use on muscles in arms and thigh areas.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level and frequency level can be adjusted by user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, arms, thighs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthy persons (for intended use)
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 tests have been conducted to verify that the subject device meets all design specifications as predicate devices per the following:
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- Waveform test report has also been conducted to verify the output parameters (waveform, shape, voltage, pulse width, frequency and so on) and output waveforms (for each mode and each channel under loads of 500, 2k, and 10k ohms) according to the requirements of the FDA "Guidance Document for Powered Muscle Stimulator 510(k)s"
The SM9065 Fitness Belt was evaluated with Safety, EMC, Biocompatibility and Waveform Test. The conclusions from testing of the SM9065 Fitness Belt demonstrate that the device is as safe and effective as the legally marketed predicate devices.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2014
Hong Qiang Xing (Shenzhen) Electronics Limited Mr. Xu Jianhua, General Manager 4F, JingCheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District Shenzhen, Guangdong Province 518102 CHINA
Re: K133108
Trade/Device Name: Fitness Belt, Model SM9065 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 20, 2014 Received: July 3, 2014
Dear Mr. Xu Jianhua:
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 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
1
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 (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Felipe Aquel -S
Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K133108
Device Name Fitness Belt, Model SM9065
Indications for Use (Describe)
The SM9065 Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.
-
The big belt is intended for use on the muscles in abdomen.
-
The small belt is intended for use on the muscles in arms and thighs areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Date: 2014.08.05 10:02:54 -04'00'
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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
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Chapter 6. 510(k) Summary
Date of the summary prepared: August 4, 2014
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
- 510(k) Owner's Name: Hong Qiang Xing (Shenzhen) Electronics Limited �
- � Address: 4F.,Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an District, Shenzhen, Guangdong Province, PRC
- � Phone: 86-755-26423615
- � Fax: 86-755-29915485-818
- Contact Person (including title): Mr. Xu Jianhua (General Manager) �
- � E-mail: info@sunmas.com
Subject Device Information 2.
- � Trade Name: Fitness Belt, Model: SM9065
- Powered muscle stimulator Common Name: �
- Stimulator, Muscle, Powered, For muscle conditioning Classification name: �
- Physical Medicine Review Panel: �
- NGX Product Code: �
- 2 Regulation Class: �
- 890.5850 Regulation Number: �
3. Predicate Device Information
| Sponsor | Red Lemon
Incorporation | SPORT-ELEC S.A. |
|----------------------|------------------------------------|-----------------------------------------|
| Device Name | X2ABS Dual
Channel Fitness Belt | SPORT-ELEC® Body
Control System '4M' |
| 510(k) Number | K102295 | K092476 |
| Product Code | NGX | NGX |
| Regulation
Number | 890.5850 | 890.5850 |
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Hong Qiang Xing (Shenzhen) Electronics Limited Sponsor: Subject Device: Fitness Belt, Model: SM9065 510(k) submission report (V1.0), Chapter 6 510(k) Summary File No.:
| Regulation Class | 2 | 2 |
|---|---|---|
| ------------------ | --- | --- |
4. Device Description
SM9065 Fitness Belt is a two channels battery operated muscle stimulation system to achieve the purpose of exercise and relaxation. It is comprised of a main device for signal generation, four belts for fixation, and series electrodes.
The big belt is intended for use on muscles in abdomen. The two small belts are intended for use on muscles in arms and thigh areas.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level and frequency level can be adjusted by user.
5. Intended Use & Indication for Use
Intended Use:
The SM9065 Fitness Belt is intended for use by healthy persons to apply trans-coetaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes:
- Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
Indication for Use:
The SM9065 Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.
-
The big belt is intended for use on the muscles in abdomen.
-
The small belt is intended for use on the muscles in arms and thighs areas.
Contraindicated use on injured or otherwise impaired muscles.
Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
6. Design
SM9065 Fitness Belt is a two channels battery operated muscle stimulation system to achieve the purpose of exercise and relaxation. It is comprised of a main device for signal generation, four belts for fixation, and series electrodes.
The big belt is intended for use on muscles in abdomen. The two small belts are intended for use on muscles in arms and thigh areas.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on
5
the skin. The parameters of the unit are controlled by the buttons. Its intensity level and frequency level can be adjusted by user.
7. Materials
There are four user directly contracting components in the subject device as the following list.
| Component of Device
Requiring
Biocompatibility | Material of
Component | Body Contact
Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
|------------------------------------------------------|------------------------------------------------------|-------------------------------------------|-----------------------------------|
| Belt | Non-woven (synthetic)
fabric in 100%
polyester | Surface-contacting
device: skin | Maximum 45 minutes
| (Sponsor: | Hong Qiang Xing (Shenzhen) Electronics Limited |
|---|---|
| Subject Device: | Fitness Belt, Model: SM9065 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 510(k) Summary |
| Elements of
| Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| ISO10993-10 | |||
| requirements. | ISO10993-10 | ||
| requirements. | |||
| Electrical Safety | Comply with IEC 60601- | ||
| 1 and IEC 60601-2-10 | Comply with IEC 60601-1 | ||
| and IEC 60601-2-10 | SE | ||
| EMC | Comply with IEC 60601- | ||
| 1-2 | Comply with IEC 60601- | ||
| 1-2 | SE |
Comparison in Detail(s):
Note 1:
Although the muscles for intended use of subject device are different from predicate devices, we can find that the predicate devices can also be used on the same muscles according to the device description of 510(k) summary. So the subject device and predicate devices have the same intended use aspect.
Note 2:
Although the "Power Source(s)", "Patient Leakage Current", "Average DC current through electrodes when device is on but no pulses are being applied", "Operating Environment", "Storage Environment" are a little different from the predicate devices, they all comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue.
Note 3:
Although the " Number of Output Intensity Level", " Method of Channel Isolation", " Timer Range", "Weight", "Dimensions" and "the electrode size" of subject device are different from the predicate devices, they are all comply with IEC 60601-2-10 requirements. So the differences of the function specifications will not raise any safety or effectiveness issue.
Note 4:
Although the "Maximum Output Voltage", "Maximum Output Current", "Pulse Duration", "Maximum pulse frequency", "Net Charge (per pulse)", "Maximum Phase Charge", "Maximum Average Current", "Maximum Current Density", "Maximum Average Power Density of subject device", "Burst Mode" "ON Time" and "OFF Time" are a little different from the predicate devices, they all comply with IEC 60601-2-10 requirement, FDA guidance requirement for Transcutaneous Electrical Nerve Stimulator for Pain Relief and FDA guidance requirement for Powered Muscle Stimulator for Muscle Conditioning. So the differences of function specification will not raise any safety or effectiveness issue.
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Conclusion
The SM9065 Fitness Belt was evaluated with Safety, EMC, Biocompatibility and Waveform Test. The conclusions from testing of the SM9065 Fitness Belt demonstrate that the device is as safe and effective as the legally marketed predicate devices.