(266 days)
No
The description focuses on electromagnetic stimulation and does not mention any AI/ML components or functionalities.
Yes
The device is described with an "Intended Use" to "Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen" and "Strengthening, Toning and Firming of buttocks and thigh," which are therapeutic claims addressing a physical condition for improvement.
No
The device is described as an "Electromagnetic Stimulator Device" used for muscle strengthening and toning, not for diagnosing any medical conditions. Its intended use is to "Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen," and "Strengthening, Toning and Firming of buttocks and thigh".
No
The device description explicitly states it consists of a main unit, handpiece tools, and a power cable, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for improving muscle tone, strengthening, and firming of the abdomen, buttocks, and thighs. This is a therapeutic or aesthetic purpose, not for diagnosing a condition or analyzing a sample from the human body.
- Device Description: The device uses electromagnetic stimulation to interact with human body tissues. This is a physical interaction with the body, not an analysis of a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting markers, diagnosing diseases, or providing information about a patient's health status based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely external and focused on stimulating muscle tissue.
N/A
Intended Use / Indications for Use
The device is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks and thighs.
Product codes
NGX
Device Description
The Electromagnetic Stimulator Device, with models FlexPulse, MagnaCore, and MagnetiKa, consists of a main unit, handpiece tools, and a power cable. The main unit has a power supply unit, a control unit, and a cooling unit. The control unit has a control element and a liquid crystal display. The handpiece tools have electromagnetic induction coils and cooling fans, it is a non-invasive device.
The device generates an electromagnetic field that interacts with human body tissues, aiding in muscle stimulation to strengthen and tone the abdomen, buttocks, and thighs. With two outputs, it allows simultaneous treatment using two applicators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, buttocks and thighs
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)
Non clinical tests were conducted to verify that the subject devices met all design specifications and was substantially equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following:
- ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010((R)2012 (Consolidated Text) Medical Electrical Equipment -- Part 1: General Requirements for Basic Safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC60601-2-10:2016, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-1-6: 2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software was considered as a "moderate" level of concern.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
February 25, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
CPMT LASER (Canadian Pioneer Medical Technology Corporation) Dr. Rashid Reza Mir Sayah Managing Director 460 Garyray Drive, North York Toronto, ON M9L1P8 Canada
Re: K241601
Trade/Device Name: EMS (FlexPulse, MagnaCore, Magnetika) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 4, 2024 Received: June 4, 2024
Dear Dr. Sayah:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely, Tushar Bansal -S
for Heather Dean, PhD
Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Electromagnetic Stimulator Device (FlexPulse, MagnaCore, MagnetiKa)
Indications for Use (Describe)
The device is indicated to be used for:
· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, Toning and Firming of buttocks and thigh
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)
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4
510(k) summary
Submitter:
CPMT Laser (Canadian Pioneer Medical Technology Corporation) 460 Garyray Drive #1, North York, Toronto, ON, M9L 1P8, Canada Contact Person: Dr. Rashid Reza Mir Sayah Phone: (437) 772-7788 Email: canadianpioneer@yahoo.com Date Prepared: February 10, 2025
Subject Device:
Trade/Device Name: Electromagnetic Stimulator Device Models: FlexPulse, MagnaCore, MagnetiKa Regulation Number: 21CFR 890.5850 Regulation Name: Stimulator, Muscle, Powered, For Muscle Conditioning Regulatory Class: II Product code: NGX 510(k) number: K241601 Manufacturer: CPMT Laser (Canadian Pioneer Medical Technology Corporation)
Predicate Device:
Trade/Device Name: BTL 799-2 Regulation Number: 21CFR 890.5850 Regulation Name: Stimulator, Muscle, Powered, For Muscle Conditioning Regulatory Class: II Product code: NGX 510(k) number: K180813 Manufacturer: BTL Industries, Inc.
Device Description:
The Electromagnetic Stimulator Device, with models FlexPulse, MagnaCore, and MagnetiKa, consists of a main unit, handpiece tools, and a power cable. The main unit has a power supply unit, a control unit, and a cooling unit. The control unit has a control element and a liquid crystal display. The handpiece tools have electromagnetic induction coils and cooling fans, it is a non-invasive device.
The device generates an electromagnetic field that interacts with human body tissues, aiding in muscle stimulation to strengthen and tone the abdomen, buttocks, and thighs. With two outputs, it allows simultaneous treatment using two applicators.
5
Indications for Use:
The device is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks and thighs.
Comparison of Technological Characteristics with the Predicate Device:
Substantial equivalence discussion
The comparison and discussion between the subject device and the predicate device is listed in the table below:
| | Subject Device | Predicate Device | Reference
Device | Comparison |
|----------------------|------------------------------|------------------------------|---------------------------------|-------------------------|
| 510(K) | K241601 | K180813 | K190456 | - |
| Manufacturer | CPMT Laser | BTL Industries,
Inc. | BTL Industries,
Inc. | - |
| Trade Name | EMS | BTL 799-2 | BTL 799-2L | - |
| Regulation
number | 21 CFR 890.5850 | 21 CFR
890.5850 | 21 CFR
890.5850 | Identical (the
same) |
| Regulation
Name | Powered muscle
stimulator | Powered muscle
stimulator | Powered
muscle
stimulator | Identical (the
same) |
| Product code | NGX | NGX | NGX | Identical (the
same) |
| Class | II | II | II | |
Table: Substantial equivalence comparison
6
| Indications for
use/Intended
use | The device is
indicated to be
used for: | The device is
indicated to be
used for: | The device is
indicated to be
used for: | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | • Improvement of
abdominal tone,
strengthening of
the abdominal
muscles,
development of
firmer abdomen.
• Strengthening,
Toning and
Firming of buttocks
and thighs. | • Improvement of
abdominal tone,
strengthening of
the abdominal
muscles,
development of
firmer abdomen.
• Strengthening,
Toning and
Firming of
buttocks and
thighs. | • Improvement
of abdominal
tone,
strengthening
of the
abdominal
muscles,
development of
firmer
abdomen.
• Strengthening,
Toning
and Firming
of buttocks
and
thighs. | Identical |
| Primary Function | Muscle stimulation | Muscle stimulation | Muscle stimulation | Identical |
|---|---|---|---|---|
| Principal of Action | Initiating action potential of nerves results in muscle contraction | Initiating action potential of nerves results in muscle contraction | Initiating action potential of nerves results in muscle contraction | Identical |
| User Interface | Touch screen | Touch screen | Touch screen | Identical |
| Touch Screen size | 15.6 inches | 15.6 inches | 15.6 inches | Identical |
| Firmware Controlled | Yes | Yes | Yes | Identical |
| Type of Energy | Magnetic field | Magnetic field | Magnetic field | Identical |
| Magnetic Field Intensity (on the coil surface) | 0.5-1.8T,±20% | 299-6 applicator: | ||
| 0.5–1.8 T | BTL 299-6 applicator: 0.5 - 1.8 T ,±20% | |||
| BTL 299-7 applicator: 0.7 - 2.0 T ,±20% | Identical | |||
| Number of Outputs | 2 | 2 | 2 | Identical |
7
| Maximum Magnetic Field Intensity at Applicator Center Surface | 1.0T±20% | BTL 299-6 applicator: 1.154 T±20%; | BTL 299-6 applicator: 1.154 T±20%;
BTL 299-7 applicator: 1.173 T±20%. | The maximum field intensity at the center surface of the applicator is 1.0T, in comparison to 1.154T for the predicate device. Nonetheless, the magnetic field intensity falls within the acceptable range of the predicate device. |
|---------------------------------------------------------------|--------------------------------|------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of Magnetic Coils in the Applicator | 1 | 1 | 1 | Identical |
| Type of Operation | Continuous | Continuous | Continuous | Identical |
| Pulse Repletion Rate | 1 – 150 Hz | 1 – 150 Hz | 1 – 150 Hz | Identical |
| Pulse Duration | $270 \pm 20% \mu s$ | $280 \pm 20% \mu s$ | BTL 299-6
applicator: $280 \pm 20% \mu s$
BTL 299-7
applicator: $190 \pm 20% \mu s$ | The subject device has a slightly shorter pulse width compared to the predicate device but falls within the range between the predicate and reference devices. |
| Pulse Amplitude | 0 – 100%, step 1% | 0 – 100% | Not publicly available | Identical |
| Selection of
parameters
(Intensity, Time) | Yes | Yes | Yes | Identical |
| Shape of
Stimulation
Pulse | Symmetrical Biphasic Sine Wave | Symmetrical Biphasic Sine Wave | Symmetrical Biphasic Sine Wave | Identical |
| Induced Current
in the Tissues | 20.6mA | 28-30mA | Not Publicly Available | The current induced in the tissue by the subject device is lower than that of the predicate device, making it safer while achieving the same effect. |
8
| Therapy Time | Up to 60 min | Up to 60 min | Up to 60 min | Identical |
|---|---|---|---|---|
| Application | Hands-free, | |||
| applicator fixed by | ||||
| fixation belt | Hands-free, | |||
| applicator fixed by | ||||
| fixation belt | Hands-free, | |||
| applicator fixed by | ||||
| fixation belt | Identical | |||
| Energy Source | 100–240 VAC, 50–60 Hz | 100–240 VAC, 50–60 Hz | 100–240 VAC, 50–60 Hz | Identical |
9
| System
Dimensions
(WxHxD) | 525x433x1279mm/
640×560×1390mm | 500×1380×580 mm
(20x55x23 in) | 500×1380×580 mm
(20x55x23 in) | The varying
dimensions do
not impact the
safety or
effectiveness of
the device. |
|---------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Environmental
Specifications | For indoor use
only | For indoor use
only | For indoor use
only | Identical |
| Ambient
Temperature | -20°C ~ +55°C | -10°C to +55°C | -10°C to +55°C | This variation
does not affect
the safety or
effectiveness of
the device. |
| Conformance
Standard | IEC 60601-1; IEC
60601-1-2; IEC
60601-1-6; IEC
60601-2-10 | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-1-6;
IEC 60601-2-10 | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-1-6;
IEC 60601-2-10 | Identical |
| Biocompatibility | ISO 10993-5 ISO
10993-10 | ISO 10993-5 ISO
10993-10 | ISO 10993-5
ISO 10993-10 | Identical |
Summary of Non-Clinical Tests:
Non clinical tests were conducted to verify that the subject devices met all design specifications and was substantially equivalent (SE) to the predicate device. The test
10
results demonstrated that the proposed device complies with the following:
● ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010((R)2012 (Consolidated Text) Medical Electrical Equipment -- Part 1: General Requirements for Basic Safety and essential performance
● IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC60601-2-10:2016, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
● IEC 60601-1-6: 2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software was considered as a "moderate" level of concern.
Conclusion
The EMS device is considered to have substantial equivalence to its predicate device. The intended uses of the proposed device are included within the scope of the predicate device. All three models fall under the umbrella of the predicate device.
Non-clinical testing has shown that the device is equally safe, effective, and is substantially equivalent to the legally marketed device.