EMS (FlexPulse, MagnaCore, Magnetika)

K241601 · Cpmt Laser (Canadian Pioneer Medical Technology Corporation) · NGX · Feb 25, 2025 · Physical Medicine

Device Facts

• Record ID: K241601
• Device Name: EMS (FlexPulse, MagnaCore, Magnetika)
• Applicant: Cpmt Laser (Canadian Pioneer Medical Technology Corporation)
• Product Code: NGX · Physical Medicine
• Decision Date: Feb 25, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 thigh

Device Story

Electromagnetic Stimulator Device (FlexPulse, MagnaCore, MagnetiKa) is a non-invasive, powered muscle stimulator. System comprises main unit (power supply, control unit with LCD, cooling unit) and handpiece tools containing electromagnetic induction coils and cooling fans. Device generates electromagnetic field interacting with human tissues to initiate nerve action potentials, resulting in muscle contraction. Operated in clinical settings; hands-free application via fixation belts. Two outputs allow simultaneous treatment. Healthcare providers select parameters (intensity, time) via touch screen. Output affects muscle conditioning; benefits include improved tone and strength in abdomen, buttocks, and thighs.

Clinical Evidence

Bench testing only. Device performance verified against design specifications and safety standards including IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-10 (nerve/muscle stimulators), IEC 60601-1-6 (usability), ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation/sensitization). Software verification and validation testing performed per FDA guidance.

Technological Characteristics

Powered muscle stimulator; magnetic field energy source. 15.6-inch touch screen interface. Magnetic field intensity 0.5-1.8T. Symmetrical biphasic sine wave pulse; 1-150 Hz repetition rate; 270±20% μs pulse duration. Two outputs. Biocompatibility per ISO 10993-5/10. Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-10.

Indications for Use

Indicated for improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen, and strengthening, toning, and firming of buttocks and thighs.

Regulatory Classification

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.

Predicate Devices

• BTL 799-2 (K180813)

Reference Devices

• BTL 799-2L (K190456)

Submission Summary (Full Text)

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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"

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(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 ([e-mail]) or phone [phone] or 301-796-7100).

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# 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

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# Indications for Use

Submission Number (if known)

K241601

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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# 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: [phone] Email: [e-mail] 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.

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#### 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<br>Device | Comparison |
|----------------------|------------------------------|------------------------------|---------------------------------|-------------------------|
| 510(K) | K241601 | K180813 | K190456 | - |
| Manufacturer | CPMT Laser | BTL Industries,<br>Inc. | BTL Industries,<br>Inc. | - |
| Trade Name | EMS | BTL 799-2 | BTL 799-2L | - |
| Regulation<br>number | 21 CFR 890.5850 | 21 CFR<br>890.5850 | 21 CFR<br>890.5850 | Identical (the<br>same) |
| Regulation<br>Name | Powered muscle<br>stimulator | Powered muscle<br>stimulator | Powered<br>muscle<br>stimulator | Identical (the<br>same) |
| Product code | NGX | NGX | NGX | Identical (the<br>same) |
| Class | II | II | II | |

#### Table: Substantial equivalence comparison

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| Indications for<br>use/Intended<br>use | The device is<br>indicated to be<br>used for: | The device is<br>indicated to be<br>used for: | The device is<br>indicated to be<br>used for: | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | • Improvement of<br>abdominal tone,<br>strengthening of<br>the abdominal<br>muscles,<br>development of<br>firmer abdomen.<br>• Strengthening,<br>Toning and<br>Firming of buttocks<br>and thighs. | • Improvement of<br>abdominal tone,<br>strengthening of<br>the abdominal<br>muscles,<br>development of<br>firmer abdomen.<br>• Strengthening,<br>Toning and<br>Firming of<br>buttocks and<br>thighs. | • Improvement<br>of abdominal<br>tone,<br>strengthening<br>of the<br>abdominal<br>muscles,<br>development of<br>firmer<br>abdomen.<br>• Strengthening,<br>Toning<br>and Firming<br>of buttocks<br>and<br>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:<br>0.5–1.8 T | BTL 299-6 applicator: 0.5 - 1.8 T ,±20%<br>BTL 299-7 applicator: 0.7 - 2.0 T ,±20% | Identical |
| Number of Outputs | 2 | 2 | 2 | Identical |

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| 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%;<br>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<br>applicator: $280 \pm 20\% \mu s$<br>BTL 299-7<br>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<br>parameters<br>(Intensity, Time) | Yes | Yes | Yes | Identical |
| Shape of<br>Stimulation<br>Pulse | Symmetrical Biphasic Sine Wave | Symmetrical Biphasic Sine Wave | Symmetrical Biphasic Sine Wave | Identical |
| Induced Current<br>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. |

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| Therapy Time | Up to 60 min | Up to 60 min | Up to 60 min | Identical |
|---------------|-----------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|-----------|
| Application | Hands-free,<br>applicator fixed by<br>fixation belt | Hands-free,<br>applicator fixed by<br>fixation belt | Hands-free,<br>applicator fixed by<br>fixation belt | Identical |
| Energy Source | 100–240 VAC, 50–60 Hz | 100–240 VAC, 50–60 Hz | 100–240 VAC, 50–60 Hz | Identical |

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| System<br>Dimensions<br>(WxHxD) | 525x433x1279mm/<br>640×560×1390mm | 500×1380×580 mm<br>(20x55x23 in) | 500×1380×580 mm<br>(20x55x23 in) | The varying<br>dimensions do<br>not impact the<br>safety or<br>effectiveness of<br>the device. |
|---------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Environmental<br>Specifications | For indoor use<br>only | For indoor use<br>only | For indoor use<br>only | Identical |
| Ambient<br>Temperature | -20°C ~ +55°C | -10°C to +55°C | -10°C to +55°C | This variation<br>does not affect<br>the safety or<br>effectiveness of<br>the device. |
| Conformance<br>Standard | IEC 60601-1; IEC<br>60601-1-2; IEC<br>60601-1-6; IEC<br>60601-2-10 | IEC 60601-1;<br>IEC 60601-1-2;<br>IEC 60601-1-6;<br>IEC 60601-2-10 | IEC 60601-1;<br>IEC 60601-1-2;<br>IEC 60601-1-6;<br>IEC 60601-2-10 | Identical |
| Biocompatibility | ISO 10993-5 ISO<br>10993-10 | ISO 10993-5 ISO<br>10993-10 | ISO 10993-5<br>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

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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.