(182 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard electrical stimulation and RF technology with safety features based on temperature sensors and pre-set parameters, not adaptive or learning algorithms.
Yes
The 'Intended Use / Indications for Use' section lists several medical applications for the EMS function, such as "Relaxation of muscle spasms," "Prevention or retardation of disuse atrophy," and "Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis," which are therapeutic in nature. While it also has an RF function, the EMS indications clearly define it as a therapeutic device.
No.
The device's Intended Use / Indications for Use section lists therapeutic applications such as relaxation of muscle spasms, prevention of disuse atrophy, and increasing blood circulation, which are all treatment-oriented. There is no mention of diagnosing conditions or analyzing medical data.
No
The device description explicitly lists multiple hardware components including handpieces, a patient switch, a cradle, hoses, a key switch, and a power cable. It also describes functions related to RF and EMS output, temperature sensing, and vacuum, all of which are hardware-dependent. The performance studies also include testing of hardware-related standards like IEC 60601-1 and IEC 60601-2-10.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed are all related to physical therapy and muscle stimulation (relaxation of spasms, preventing atrophy, increasing circulation, muscle re-education, range of motion, preventing venous thrombosis). These are all applications performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details handpieces that apply energy (RF and EMS) to the patient's body. There is no mention of analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
- Reagents, calibrators, or controls used for sample analysis.
The device is clearly designed for therapeutic and rehabilitative purposes applied externally to the patient.
N/A
Intended Use / Indications for 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
Product codes
IPF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-Clinical (Bench) Performance Data:
- 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.
Key Metrics
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
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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
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
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
| 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 |
| Suwon-si, Gyeonggi-do, Republic of Korea | |
| Telephone No.: | +82-31-5182-8588 |
Official Correspondent: Moon-young Han
| Correspondent: | WEERO Co.,Ltd. |
|---|---|
| Address: | A205 VentureValley II, 142-10, Saneop-ro 156beon-gil, |
| Gwonseon-gu, Suwon-si, Gyeonggi-do, Republic of Korea | |
| Telephone No.: | +82-31-5182-8588 |
| Email: | ra@weeroweero.com |
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 | ||
| 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
5
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 | |||
| Applicator | Evolve System with the Tone | ||||
| 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 | ||||
| Class II | IPF, GZJ, PBX | ||||
| Class II | IPF, GZJ | ||||
| Class II | IPF, GZJ | ||||
| Class II | The eMVFit device follows | ||||
| the same Product codes(IPF) | |||||
| as the predicate device and | |||||
| eMVFit does not use the code | |||||
| GZJ: Transcutaneous | |||||
| electrical nerve stimulator for | |||||
| pain relief. Therefore, eMVFit | |||||
| does not have the indications | |||||
| for use of the GZJ Product | |||||
| Code. | |||||
| This does not raise new | |||||
| questions of safety and | |||||
| effectiveness. | |||||
| Indications | |||||
| for use | • 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 | • 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 | • 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 | -Relaxation of muscle spasms | ||||
| -Retardation or prevention of | |||||
| disuse atrophy | |||||
| -Increased local blood circulation | |||||
| -Re-Educating muscles | |||||
| -Maintaining or increasing range | |||||
| of motion. | |||||
| -Immediate post-surgical | |||||
| stimulation of calf muscles to | |||||
| prevent venous thrombosis | Same |
6
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]
7
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 | |||
| Applicator | Evolve System with the Tone | ||||
| Applicator | TimeWaver Frequency | Comparison | |||
| Manufacturer | WEERO Co.,Ltd. | INMODE LTD. | INMODE LTD. | TimeWaver Production GmbH | |
| 510(k) No. | K210877 | K201285 | K212832 | ||
| Weight Console | |||||
| Weight applicator | 48.0 kg [106 lbs.] | ||||
| MULTI handpiece: | |||||
| 0.52 kg [1.1 lbs.] | |||||
| EMS handpiece: | |||||
| 0.42 kg [0.9 lbs.] | 33.0 Kg [73 lbs.] | ||||
| T3: 0.16 Kg [0.4 lbs.] | 33.0 Kg [73 lbs.] | ||||
| Tone: 0.22 Kg [0.5 lbs.] | - | Different | |||
| *Note 2 | |||||
| Power Source(s) | Same | ||||
| Method of Line | |||||
| Current Isolation | Independent transformer | ||||
| isolated | Independent | ||||
| transformer isolated | Independent transformer | ||||
| isolated | - | Same | |||
| Electrical Type | Type BF | Type BF | Type BF | - | Same |
| Patient Leakage | |||||
| Current |
- Normal Condition
(μΑ) |