eMVFit (MVF-10M)

K240992 · Weero Co., Ltd. · IPF · Oct 10, 2024 · Physical Medicine

Device Facts

• Record ID: K240992
• Device Name: eMVFit (MVF-10M)
• Applicant: Weero Co., Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Oct 10, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EMS is used for: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

Device Story

eMVFit (MVF-10M) is a powered muscle stimulator used in clinical settings by healthcare providers. It consists of a console with an LCD touch screen, MULTI handpiece (RF and EMS functions), and EMS handpiece. The device delivers electrical energy to muscles via symmetrical biphasic rectangular waveforms. In MULTI mode, it provides RF energy for heating with integrated vacuum and cooling for skin safety; a temperature sensor automatically disables output if skin surface exceeds 43°C. In EMS mode, it provides electrical stimulation for muscle therapy. The device features 8 output channels, independent transformer isolation, and automatic overload/no-load trip mechanisms. Providers use the interface to set treatment parameters (intensity, timer). The device aids in muscle rehabilitation, spasm reduction, and circulation improvement, benefiting patients by preventing atrophy and venous thrombosis post-surgery.

Clinical Evidence

Bench testing only. Performance testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and nerve/muscle stimulator requirements (IEC 60601-2-10). Biocompatibility was evaluated per ISO 10993-10 and ISO 10993-23. Software verification was conducted per IEC 62304. Usability was documented per IEC 60601-1-6. Testing confirmed output parameters and safety features meet design specifications and FDA guidance for powered muscle stimulators.

Technological Characteristics

Powered muscle stimulator (Class II, IPF). Features console with LCD touch screen, MULTI handpiece (RF/EMS), and EMS handpiece. Energy source: 100-240 Vac input, 24 Vdc internal. Output: Symmetrical biphasic rectangular waveform, 3-200 Hz frequency, 150 µs pulse width. Connectivity: Standalone. Safety: Temperature sensor (43°C cutoff), independent transformer isolation, Type BF electrical classification. Complies with IEC 60601-1, IEC 60601-2-10, and ISO 14971.

Indications for Use

Indicated for patients requiring muscle stimulation for relaxation of spasms, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, maintenance/increase of range of motion, and immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

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

• Evolve System with the T3 Applicator (K210877)
• Evolve System with the Tone Applicator (K201285)

Reference Devices

• TimeWaver Frequency (K212832)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 10, 2024

WEERO Co.,Ltd. Moon Young Han Regulatory Affairs A-605, Venture Valley II, 142-10, Saneop-Ro 156 Beon-Gil, Gwonseon-Gu Suwon-Si.Gyeonggi-Do Suwon. Gyeonggi 16648 South Korea

Re: K240992

Trade/Device Name: eMVFit (MVF-10M) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: April 2, 2024 Received: April 11, 2024

## Dear Moon Young Han:

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" (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).

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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 Rule"). 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-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,

# Jitendra V. Virani -S

CDR Jitendra Virani, MS, MBA Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

### K240992

Device Name

eMVFit (MVF-10M)

Indications for Use (Describe)

EMS is used for:

- · Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increasing local blood circulation
- · Muscle re-education
- · Maintaining or increasing range of motion
- · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

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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| eMVFit |
|--------|
|--------|

### 510(k) Summary

### 1. Submitter and US Official Correspondent

| Submitter : | WEERO Co.,Ltd. |
|----------------|----------------------------------------------------------------------------------------------------------------|
| Address: | A205 Venture Valley II, 142-10, Saneop-ro 156beon-gil, Gwonseon-gu<br>Suwon-si, Gyeonggi-do, Republic of Korea |
| Telephone No.: | [phone] |

## Official Correspondent: Moon-young Han

| Correspondent: | WEERO Co.,Ltd. |
|----------------|----------------------------------------------------------------------------------------------------------------|
| Address: | A205 VentureValley II, 142-10, Saneop-ro 156beon-gil,<br>Gwonseon-gu, Suwon-si, Gyeonggi-do, Republic of Korea |
| Telephone No.: | [phone] |
| Email: | [e-mail] |

### 2. Device Information

| Trade/Device Name: | eMVFit / MVF-10M |
|----------------------|-------------------------------------|
| Regulation Name: | - Powered Muscle Stimulator |
| Classification Name: | - Stimulator, Muscle, Powered |
| Product Code: | IPF |
| Device Class: | Class II (Regulation 21CFR890.5850) |

### 3. Predicate Device(Equivalent Legally Marketed Device)

| Manufacturer | Device | 510(k) No. |
|------------------------------|----------------------------------------|------------|
| Main Predicate | | |
| INMODE LTD. | Evolve System with the T3 Applicator | K201285 |
| Reference Predicate | | |
| INMODE LTD. | Evolve System with the Tone Applicator | K201285 |
| TimeWaver<br>Production GmbH | TimeWaver Frequency | K212832 |

### Description of the Device 4.

eMVFit has MULTI handpiece, EMS handpiece, patient switch, cradle, distilled water injection hose & funnel, key switch and power cable.

eMVFit has a user interface including an LCD touch screen and has MULTI mode and EMS mode. MULTI mode has RF and EMS functions that use the MULTI handpiece.

In the case of RF, the target temperature can be set and a vacuum can be used together, and a cooling function can be used as a safety system to prevent burns on the skin surface.

In addition, the MULTI handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43 ℃.

EMS mode has an EMS function that uses the EMS handpiece.

### ട്. Indications for use (intended use)

EMS is used for:

- · Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increasing local blood circulation
- Muscle re-education
- · Maintaining or increasing range of motion
- · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

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### 6. Substantial Equivalence Discussion

## 1) Comparison Information

| Name | Subject device | Main Predicate device | Reference Predicate device | Reference Predicate device | Comparison |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | eMVFit(MVF-10M) | Evolve System with the T3<br>Applicator | Evolve System with the Tone<br>Applicator | TimeWaver Frequency | Comparison |
| Manufacturer | WEERO Co.,Ltd. | INMODE LTD. | INMODE LTD. | TimeWaver Production GmbH | |
| 510(k) No. | - | K210877 | K201285 | K212832 | |
| Product Code, Class | IPF<br>Class II | IPF, GZJ, PBX<br>Class II | IPF, GZJ<br>Class II | IPF, GZJ<br>Class II | The eMVFit device follows<br>the same Product codes(IPF)<br>as the predicate device and<br>eMVFit does not use the code<br>GZJ: Transcutaneous<br>electrical nerve stimulator for<br>pain relief. Therefore, eMVFit<br>does not have the indications<br>for use of the GZJ Product<br>Code.<br>This does not raise new<br>questions of safety and<br>effectiveness. |
| Indications<br>for use | • Relaxation of muscle spasms<br>• Prevention or retardation of<br>disuse atrophy<br>• Increasing local blood<br>circulation<br>• Muscle re-education<br>• Maintaining or increasing range<br>of motion<br>• Immediate postsurgical<br>stimulation of calf muscles to<br>prevent venous thrombosis | • Relaxation of muscle spasms<br>• Prevention or retardation of<br>disuse atrophy<br>• Increasing local blood<br>circulation<br>• Muscle re-education<br>• Maintaining or increasing range<br>of motion<br>• Immediate postsurgical<br>stimulation of calf muscles to<br>prevent venous thrombosis | • Relaxation of muscle spasms<br>• Prevention or retardation of<br>disuse atrophy<br>• Increasing local blood<br>circulation<br>• Muscle re-education<br>• Maintaining or increasing range<br>of motion<br>• Immediate postsurgical<br>stimulation of calf muscles to<br>prevent venous thrombosis | -Relaxation of muscle spasms<br>-Retardation or prevention of<br>disuse atrophy<br>-Increased local blood circulation<br>-Re-Educating muscles<br>-Maintaining or increasing range<br>of motion.<br>-Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis | Same |

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#### Reference Predicate device Reference Predicate device Name Subject device Main Predicate device Evolve System with the Tone Evolve System with the T3 Device Name eMVFit(MVF-10M) TimeWaver Frequency Applicator Applicator Comparison TimeWaver Production GmbH Manufacturer WEERO Co.,Ltd. INMODE LTD. INMODE LTD. K210877 K201285 510(k) No. K212832 The EVOLVE System with T3 The EVOLVE System with The eMVFit with handpiece Applicator consists of an AC/DC Tone Applicator consists of consists of an AC/DC power power supply unit, an AC/DC power supply unit, supply unit, controller and user Controller and user interface controller and user interface interface including an LCD touch including an LCD touch screen. including an LCD touch screen. screen. The delivery of the The delivery of the RF/electrical The delivery of the electrical electrical energy is controlled by energy is controlled by a energy is controlled by a a Start/Stop button positioned on Start/Stop button positioned on Start/Stop button positioned on the front panel. the front panel. Different the front panel. Design The System supports the The System supports the *Note 1 The System supports the following components: following components: following components: • LCD display touch Screen • LCD display touch Screen • LCD display touch Screen • Audio loudspeaker • Audio loudspeaker • Audio loudspeaker · 24V AC/DC power Supply · 48V AC/DC power Supply · 48V AC/DC power Supply • Controller • Controller • Controller • The System operates while The System operates while · The System operates while connected to the handpiece. connected to the T3 Applicator in connected to the Tone Applicator. RF mode or in EMS/TENs mode. The eMVFit consists of the The EVOLVE System consists of The EVOLVE System consists of following components: the following components: the following components: Console, including a power · Console, including a power Console, including a power supply unit, controller and user supply unit, controller and supply unit, controller and user interface including an LCD touch user interface including an LCD interface including an LCD touch Different Components console *Note 3 screen. touch screen. screen. Handpiece with up to 8 units · T3 Applicator with up to 6 units Tone applicator with up to 4 units connected to the console via 8 connected to the console via 6 connected to the console via 4 designated cables and 8 designated designated cables and 6 designated cables and 4 connection ports. designated connection ports. designated connection ports. 44cm W x 70cm D x 120cm H [17.3'' W x 27.5' D x 47'' H] 46cm W x 46cm D x 100cm H 46cm W x 46cm D x 100cm H Dimension Console MULTI handpiece [18.2'' W x 18.2'' D x 44'' H] [18.2'' W x 18.2'' D x 44'' H] [W x H x D] 8cm L x 11.5cm D Different [3" L x 4.5" D] T3 Applicator unit: Tone Applicator *Note 2 Applicator 67.3mm L x 54.3mm D 12cm L x 10cm D [L X D] [2.7'' L x2.2'' D] [4.7'' L x 4'' D] EMS handpiece 10cm L x 13cm D [4'' L x 5'' D]

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### 510(k) Summary

| Name | Subject device | Main Predicate device | Reference Predicate device | Reference Predicate device | Comparison |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------|----------------------------|----------------------|
| Device Name | eMVFit(MVF-10M) | Evolve System with the T3<br>Applicator | Evolve System with the Tone<br>Applicator | TimeWaver Frequency | Comparison |
| Manufacturer | WEERO Co.,Ltd. | INMODE LTD. | INMODE LTD. | TimeWaver Production GmbH | |
| 510(k) No. | | K210877 | K201285 | K212832 | |
| Weight Console<br>Weight applicator | 48.0 kg [106 lbs.]<br>MULTI handpiece:<br>0.52 kg [1.1 lbs.]<br>EMS handpiece:<br>0.42 kg [0.9 lbs.] | 33.0 Kg [73 lbs.]<br>T3: 0.16 Kg [0.4 lbs.] | 33.0 Kg [73 lbs.]<br>Tone: 0.22 Kg [0.5 lbs.] | - | Different<br>*Note 2 |
| Power Source(s) | | | | | Same |
| Method of Line<br>Current Isolation | Independent transformer<br>isolated | Independent<br>transformer isolated | Independent transformer<br>isolated | - | Same |
| Electrical Type | Type BF | Type BF | Type BF | - | Same |
| Patient Leakage<br>Current<br>- Normal Condition<br>(μΑ) | <100uA patient leakage | <100uA patient leakage | <100uA patient leakage | <100uA patient leakage | Same |
| Patient Leakage<br>Current<br>- Single Fault<br>Condition(μΑ) | <300uA line leakage | <300uA line leakage | <300uA line leakage | <100uA patient leakage | Same |
| Number of Output<br>Modes | 2 | Unknown | 2 | 2 | Same |
| Number of Output<br>Channels | 8 | 6 | 2 | 2 | Different<br>*Note 3 |

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#### Main Predicate device Reference Predicate device Reference Predicate device Name Subject device Evolve System with the T3 Evolve System with the Tone Device Name eMVFit(MVF-10M) TimeWaver Frequency Comparison Applicator Applicator TimeWaver Production GmbH Manufacturer INMODE LTD. INMODE LTD. WEERO Co.,Ltd. 510(k) No. K210877 K201285 K212832 -Synchronous or See Output Specifications Below See Output Specifications Below See Output Specifications Below Same -Alternating Method of Channel Through transformers and Through transformers and Through transformers and Same Isolation isolators isolators isolators Regulated Current or Regulated voltage on all Regulated voltage on all Regulated Voltage Regulated voltage channels channels both Same (output signals only) With current limit With current limit Software/Firmware/ Microprocessor Yes Yes Yes Yes Same Control Automatic Overload Yes Yes Yes Yes Same Trip Automatic No-Load Yes Yes Yes Yes Same Trip Automatic Shut Off Yes Yes, On/off switch Yes, On/off switch Yes, PC-software Same Patient Override Yes Yes Yes Yes, PC-software Same Control Indicator Display Yes Yes Yes Yes Same

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| Name | Subject device | Main Predicate device | Reference Predicate device | Reference Predicate device | |
|-------------------------------------------------------------------|----------------------------------|-----------------------------------------|-------------------------------------------|----------------------------------|----------------------|
| Device Name | eMVFit(MVF-10M) | Evolve System with the T3<br>Applicator | Evolve System with the Tone<br>Applicator | TimeWaver Frequency | Comparison |
| Manufacturer | WEERO Co.,Ltd. | INMODE LTD. | INMODE LTD. | TimeWaver Production GmbH | |
| 510(k) No. | | K210877 | K201285 | K212832 | |
| On/Off Status | Yes | Yes | Yes | Yes | Same |
| Battery | No battery | No battery | No battery | | Same |
| Voltage/Current level | Yes | Yes, voltage levels | Yes, voltage levels | Yes | Same |
| Timer<br>Range(Minutes) | 15, 30, 45, 60 [minutes] | 0-60 [minutes] | 0-60 [minutes] | | Same |
| Compliance with 21<br>CFR<br>890.5850 (IPF) | Yes | Yes | Yes | Yes | Same |
| EMS Output Mode | | | | | |
| Output<br>Specifications:<br>Waveform | Symmetrical Biphasic Waveform | Symmetrical Biphasic Waveform | Symmetrical Biphasic Waveform | | Same |
| Pulse Shape | Rectangular | Rectangular | Rectangular | Rectangular | Same |
| | 34V @ $500Ω$ | 30V @ $500Ω$ | 56V @ $500Ω$ | 0.25V @ $500Ω$ | |
| Maximum Output<br>Voltage(± 10%) | 43V @ $2kΩ$ | 54V @ $2kΩ$ | 56V @ $2kΩ$ | 1.2V @ $2kΩ$ | Different<br>*Note 4 |
| | 43V @ $10kΩ$ | 54V @ $10kΩ$ | 56V @ $10kΩ$ | 12V @ $10kΩ$ | |
| Name | Subject device | Main Predicate device | Reference Predicate device | Reference Predicate device | |
| Device Name | eMVFit(MVF-10M) | Evolve System with the T3<br>Applicator | Evolve System with the Tone<br>Applicator | TimeWaver Frequency | Comparison |
| Manufacturer | WEERO Co.,Ltd. | INMODE LTD. | INMODE LTD. | TimeWaver Production GmbH | |
| 510(k) No. | | K210877 | K201285 | K212832 | |
| Maximum Output<br>Current(± 10%) | 68 mA @500Ω | 60 mA @500Ω | 92.86 mA @500Ω | 0.5 mA @500Ω | Different<br>*Note 4 |
| | 20 mA @2kΩ | 27 mA @2kΩ | 26.7 mA @2kΩ | 0.5 mA @2kΩ | |
| | 5 mA @10kΩ | 5.4 mA @10kΩ | 5.4 mA @10kΩ | 0.5 mA @10kΩ | |
| Pulse Width (µsec) -<br>The output active<br>positive pulse width | 150 [µs] | 20 to 400 [µs] | 20 to 400 [µs] | 5000 [µs] | Different<br>*Note 5 |
| Frequency (Hz) | 3 to 200 [Hz] | 3 to 200 [Hz] | 3 to 200 [Hz] | 50 [Hz] | Same |
| Net Charge @ 500<br>ohms [µC/pulse] | 0 [μC] @ 500Ω | 0 [μC] @ 500Ω | 0 [μC] @ 500Ω | - | Same |
| Maximum Phase<br>Charge[µC] | 10.2 [μC] @500Ω | 24 [μC] @500Ω | 43.2 [μC] @500Ω | 2.5 [μC] @500Ω | Different<br>*Note 6 |
| Maximum Current<br>Density[mA/cm²] | 0.62 [mA/cm²]<br>Surface = 13cm² | 0.74 [mA/cm²]<br>Surface = 6.46cm² | 0.72 [mA/cm²]<br>Surface = 12cm² | 0.02 [mA/cm²]<br>Surface = 25cm² | Different<br>*Note 7 |
| Maximum Power<br>Density[mW/cm²] | 21.3[mW/cm²] @ 500Ω | 22.2 [mW/cm²] @ 500Ω | 55[mW/cm²] @ 500Ω | 0.005 [mW/cm²]<br>@ 500Ω | |

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### 510(k) Summary

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| | 510(k) Summary |
|--|----------------|
|--|----------------|

| Name | Subject device | Main Predicate device | Reference Predicate device | Reference Predicate device | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|----------------------------|------------|
| Device Name | eMVFit(MVF-10M) | Evolve System with the T3<br>Applicator | Evolve System with the Tone<br>Applicator | TimeWaver Frequency | |
| Manufacturer | WEERO Co.,Ltd. | INMODE LTD. | INMODE LTD. | TimeWaver Production GmbH | |
| 510(k) No. | - | K210877 | K201285 | K212832 | |
| Burst Mode (i.e.,<br>pulse trains)<br>a. Pulses per burst<br>b. Bursts per second<br>c. Burst duration<br>(seconds)<br>d. Duty Cycle [Line<br>(b) x Line (c)] | Yes:<br>a. 3 - 200<br>b. 1<br>c. 1-60 sec<br>d. Time on / off | Yes:<br>a. 3 - 200<br>b. 1<br>c. 1-60 sec<br>d. Time on / off | Yes:<br>a. 3 - 200<br>b. 1<br>c. 1-60 sec<br>d. Time on / off | | Same |
| On Time (sec.) | 1 -60 [sec] | 1 -60 [sec] | 1 -60 [sec] | | Same |
| Off Time (sec.) | 1 -60 [sec] | 1 -60 [sec] | 1 -60 [sec] | | Same |
| Treatment Time<br>(min) - the time limit<br>that will put the<br>system in STOP state<br>Level – The output<br>intensity level | 15, 30, 45, 60 [min]<br>1 to 50 | Up to 60 min. | Up to 60 min.<br>1 to 50 | | Same |

### 2) Substantial Equivalence Discussion

There are differences on a few things. However, these differences do not affect the significant equivalence of the device and its predicates.

## Note 1: "Power supply differences"

The input power between the subject device is the same at 100-240 Vac, and there is a difference in the DC output voltage.

The subject device uses 24 Vdc and the predicate devices use 48 Vdc(K210877, K201285) or 9 Vdc(K212832).

But the power supply voltage can vary depending of the device, and the effectiveness of the device is determined by the output parameter, not the power supply voltage.

{12}------------------------------------------------

### 510(k) Summary

We have confirmed through performance testing that the intenties are output when the 24Vdc power is applied to the components, and the safety has been verified through the IEC 60601-1 test.

These differences in power supply do not raise new questions about safety and effectiveness.

### Note 2: "Weight" and "Dimensions"

Although "Weight" and "Dimensions" of subject device are different from the predicate device, they all comply with IEC 60601-2-10 requirements, thus the differences of the functions does not raise any safety or effectiveness issue.

### Note 3: Number of Output Channels

Although the "Number of Output Channels" is different from the predicate device they all omply with IEC 60601-1 and the difference doesn't impact essential performance, basic safety or substantial equivalence.

## Note 4: "Maximum Output Voltage" and "Maximum Output Current"

Since the maximum output voltage & current of the subject device are within the range of the two predicate devices (K201265. K210877), they do not raise new questions about safety and effectiveness.

In addition, there is no concern about overstimulation because the subject device to the precicate device (K201285), and there is no concern about under stimulation because the subject device has higher output compared to the predicate device (K212832).

The subject device was tested and is compliant with IEC 60601-2-10.

Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence.

### Note 5: "Pulse Width"

Although the "Pulse Width" of the subject device, it is included in the pulse with range of the predicate device and was all tested and compliant with IEC 60601-2-10. Therefore doesn't impact essential performance, basic safety or substantial equivalence.

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### Note 6: "Maximum Phase Charge"

Maximum Phase Charge is related to the maximum output with, and because the predicate device has various pulse widths, the range of phase charge depends on the pulse width range. For the predicate device (K210877), the phase charge ranges from 1.2 µC to 24 µC. Because the phase charge of the subject device is within the range of the new questions about safety and effectiveness. In addition, even though the Maximum Phase Charge of the predicate device, is lower than the subject device, it has the same indication for use as the subject device.

### Note 7: "Maximum Current Density" and "Maximum Power Density"

The Maximum Current Density and Maximum Power Density of the subject device (K210877) are very similar.

Usability and risk analysis have also been performed to support proof of safety and effectiveness of the subject device.

In addition, even though the predicate device (K212832) has much lower maximum power density than the subject device it has the same indication for use as the subject device the difference between the subject device and the predicate devices does not raise new questions about safety and effectiveness.

The Maximum Power Density for the subject device is less than 0.25 Watts per square conductive surface area to reduce the nisk of thermal burns and The Maximum Current Density for all waveforms of the new device is compliant with FDA Guidance Document for Powered Muscle Stimulator 510(k)s, thus the difference doesn't impact essential performance, basic safety or substantial equivalence.

### 3) Conclusion

"Evolve System with the T3 Applicator", "Evolve System with the Tone Applicator" were chosen as predicate devices for the subject device in consideration of the intentions, performance and principles of operation. Minor variations between the subject and the predicate device were found and listed within the amount of testing, including electrical safety, electromagnetic compatibility, performance, software verification and usability testing were performed to support the claims of appropriately chosen predicate device. The test results show that the specifications and performance of eMVFit are as safe and effective as legally marketed predicate devices. Therefore, it is concluded that the eMVFit is substantially equivalent to the legally marketed predicate devices.

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### 510(k) Summary

### Non-Clinical (Bench) Performance Data: 7.

As part of demonstrating safety and effectiveness of the eMVFit and in showing substantial equivalence to the 510(k) submission, we completed a number of non-clinical performance tests against applicable standards.

- Basic safety and essential performance of the eMVFit was tested and evaluated according to the IEC 60601-1:2005/A2:2020.
- Effect to the device by electromagnetic disturbances was tested and evaluated according to the FDA-recognized consensus standard EC 60601-1-2:2014/A1:2020.
- Particular requirements for the basic safety and essential performance of nerve and muscle sumulated according to the IEC 60601-2-10:2012/A2:2023.
- Risk management was recorded by referring to ISO 14971:2019.
- Usability was documented by referring to IEC 60601-1-6:2010/A2:2020.
- Biocompatibility was tested and evaluated according to ISO 10993-10:2021, and ISO 10993-10:2021, and ISO 10993-23:2021.
- Software was tested and evaluated according to IEC 62304:2015
- Content of Premarket Submissions for Device Software Functions

The eNVFit passed all the testing in accordance with internal requirements, national standards shown above, to support substantial equivalence of the subject device.

Also, to demonstrate that the eMVFit meets all design specifications and performance requirements, and to measurements of eM VFit and to compare the output parameters with proclinical bench testing was performed in accordance with the internal process in compliance with the recommendations of the FDA Guidance Document for Powered Muscle Stimulator 510(k)s.

The testing results support that the requiremance and electrical safety were met for the acceptance of the device. The eMVFit passed all testing and supports the claims of substantial equivalence to the predicate device.

### Sterilization/Disinfection/Cleaning/Shelf Life 8.

The eMVFit is intended for multiple use and therefore must be cleaned according to the instructions for Use. There are no sterilized parts or accessories involved with this device.

### 9. Conclusion

Based on the companison with the predicate devices and on the non-clinical performance testing that the eMVFit is as sate and effective as the predicate devices, it can be concluded that the eMVFit is substantially equivalent to the legally marketed predicate devices.