(379 days)
No.
The document describes a medical device (EMS/TENS) with various treatment modes. It details the device components, functionalities, safety regulations, and performance testing. Crucially, the document explicitly states "Not Found" for "Mentions AI, DNN, or ML" and describes a simple temperature-based automatic shut-off mechanism rather than AI-driven control.
Yes
The device is described with "Intended Use / Indications for Use" for conditions such as muscle spasms, disuse atrophy, pain relief, and prevention of venous thrombosis, which are all therapeutic applications. Additionally, it mentions being cleared under regulation for "relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation."
No
The device description and intended use clearly outline therapeutic applications (relaxation of muscle spasms, pain relief, muscle re-education, etc.) rather than diagnostic purposes (identifying or characterizing disease/condition).
No
The device description explicitly lists several hardware components like handpieces, a micro cable, tips (ball type, T type, COMB type), and a power adaptor & cable. It also describes physical functions such as radio frequency and low frequency, along with a temperature sensor, none of which are purely software. Furthermore, the performance studies include extensive electrical and mechanical safety testing, which is only applicable to hardware devices.
No.
The device's intended use is for therapeutic applications like muscle stimulation and pain relief, none of which involve in vitro examination of human specimens.
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
TENS is used for:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
Product codes
IPF, GZJ
Device Description
EVE Synergy has Synergy handpiece(1EA), Pro handpiece(2EA), Micro cable, Tip(Ball type, T type, COMB type) and Power adaptor & cable.
EVE Synergy has Synergy mode and Pro mode.
Synergy mode has radio frequency and low frequency functions using a synergy handpiece. The Synergy handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43℃.
Pro mode has low frequency function that uses the Pro handpiece with tip.
It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission.
The EVE Synergy consists of an AC/DC power supply unit, controller, and user interface including an LCD touch screen. The delivery of the electrical energy is controlled by a Start/Stop button positioned on the front panel.
The System supports the following components:
▪ LCD display touch screen
▪ Audio loudspeaker
▪ 24V AC/DC power supply
▪ Controller
The EVE Synergy consists of the following components:
▪ Power supply unit, Console, including controller and user interface including an LCD touch screen.
▪ Handpieces with up to 3 units connected to the console via 3 designated cables and 3 designated connection ports.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical (bench) performance testing was conducted to demonstrate safety and effectiveness and substantial equivalence.
- Basic safety and essential performance was tested and evaluated according to IEC 60601-1:2005/A2:2020.
- Effect to the device by electromagnetic disturbances was tested and evaluated according to IEC 60601-1-2:2014/A1:2020.
- Particular requirements for the basic safety and essential performance of nerve and muscle stimulators were tested and evaluated according to 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.
- Software was tested and evaluated according to IEC 62304:2015.
- Nonclinical 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 to measure the accuracy of the output parameters and compare them with predicate devices.
Key Results: The EVE Synergy passed all the testing, demonstrating conformance with device design requirements and applicable standards. The test results show that the specifications and performance of EVE Synergy are as safe and effective as legally marketed predicate devices.
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).
FDA 510(k) Clearance Letter - EVE Synergy (EVE-20M)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 4, 2025
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
Korea, South
Re: K241433
Trade/Device Name: EVE Synergy (EVE-20M)
Regulation Number: 21 CFR 890.5850
Regulation Name: Powered Muscle Stimulator
Regulatory Class: Class II
Product Code: IPF, GZJ
Dated: May 17, 2024
Received: May 21, 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"
Page 2
K241433 - Moon Young Han Page 2
(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 QS 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K241433 - Moon Young Han Page 3
Sincerely,
Jitendra V. Virani -S
CDR Jitendra Virani, MS, MBA
Assistant Director
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K241433
Device Name: EVE Synergy (EVE-20M)
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
TENS is used for:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
EVE Synergy 510(k) Summary_K241433
1. Submitter and US Official Correspondent
Submitter: WEERO Co.,Ltd.
Address: A205 VentureValley II, 142-10, Saneop-ro 156beon-gil, Gwonseon-gu, Suwon-si, Gyeonggi-do, Republic of Korea
Telephone No.: +82-31-427-0787
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.: +82-31-427-0787
Email: ra@weeroweero.com
Date prepared: May 26, 2025
2. Device Information
Trade/Device Name: EVE Synergy / EVE-20M
Regulation Name:
- Powered Muscle Stimulator
- Transcutaneous electrical nerve stimulator for pain relief
Classification Name:
- Stimulator, Muscle, Powered
- Stimulator, Nerve, Transcutaneous, For Pain Relief
Product Code: IPF, GZJ
Regulatory Class: Class II
Regulation Number: 21CFR890.5850, and 21CFR882.5890
3. Predicate Device(Equivalent Legally Marketed Device)
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Primary Predicate Device | ||
| INMODE LTD. | EVOLVE System with the T3 Applicator | K210877 |
| Secondary Predicate Device | ||
| INMODE LTD. | EVOLVE System with the Tone Applicator | K201285 |
4. Description of the Device
EVE Synergy has Synergy handpiece(1EA), Pro handpiece(2EA), Micro cable, Tip(Ball type, T type, COMB type) and Power adaptor & cable.
EVE Synergy has Synergy mode and Pro mode.
Synergy mode has radio frequency and low frequency functions using a synergy handpiece. The Synergy handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43℃.
Pro mode has low frequency function that uses the Pro handpiece with tip.
It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and
Page 6
was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission.
5. 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
TENS is used for:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
Page 7
6. Substantial Equivalence Discussion
1) Comparison Information
| Name | Subject device | Primary Predicate Device | Secondary Predicate device |
|---|---|---|---|
| Comparison Device Name | EVE Synergy(EVE-20M) | EVOLVE System with the T3 Applicator | EVOLVE System with the Tone Applicator |
| Manufacturer | WEERO Co.,Ltd. | InMode Ltd. | InMode Ltd. |
| 510(k) No. | K241433 | K210877 | K201285 |
| Product Code, Class | IPF, GZJ Class II | IPF, GZJ Class II | IPF, GZJ Class II |
| 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 post-surgical stimulation of calf muscles to prevent venous thrombosis |
TENS is used for:
• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain | EMS mode is intended 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 post-surgical stimulation of calf muscles to prevent venous thrombosis
TENS mode is intended for:
• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain | The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas.
The EVOLVE System with Tone Applicator is designed to operate in two modes – EMS and TENS.
In EMS mode it 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 post-surgical stimulation of calf muscles to prevent venous thrombosis
And in TENS mode is intended for
• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain | Identical |
Page 8
| Name | Subject device | Primary Predicate Device | Secondary Predicate device | Comparison |
|---|---|---|---|---|
| Device Name | EVE Synergy(EVE-20M) | EVOLVE System with the T3 Applicator | EVOLVE System with the Tone Applicator | |
| Manufacturer | WEERO Co.,Ltd. | InMode Ltd. | InMode Ltd. | |
| 510(k) No. | K241433 | K210877 | K201285 | |
| Design | The EVE Synergy consists of an AC/DC power supply unit, controller, and user interface including an LCD touch screen. The delivery of the electrical energy is controlled by a Start/Stop button positioned on the front panel. |
The System supports the following components:
▪ LCD display touch screen
▪ Audio loudspeaker
▪ 24V AC/DC power supply
▪ Controller | The EVOLVE System with T3 Applicator consists of an AC/DC power supply unit, Controller and user interface including an LCD touch screen. The delivery of the RF/electrical energy is controlled by a Start/Stop button positioned on the front panel.
The System supports the following components:
• LCD display touch Screen
• Audio loudspeaker
• 48V AC/DC power Supply
• Controller | The EVOLVE System with Tone Applicator consists of an AC/DC power supply unit, controller, and user interface including an LCD touch screen. The delivery of the electrical energy is controlled by a Start/Stop button positioned on the front panel.
The System supports the following components:
▪ LCD display touch screen
▪ Audio loudspeaker
▪ 48V AC/DC power supply
▪ Controller | Not identical.
The subject device was tested and is compliant with IEC60601-1 and IEC 60601-2-10. Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence. |
| Components Console | The EVE Synergy consists of the following components:
▪ Power supply unit, Console, including controller and user interface including an LCD touch screen.
▪ Handpieces with up to 3 units connected to the console via 3 designated cables and 3 designated connection ports. | The EVOLVE System consists of the following components:
• Console, including a power supply unit, controller and user interface including an LCD touch screen.
• T3 Applicator with up to 6 units connected to the console via 6 designated cables and 6 designated connection ports. | The EVOLVE System consists of the following components:
▪ Console, including a power supply unit, controller and user interface including an LCD touch screen.
▪ Tone applicator with up to 4 units connected to the console via 4 designated cables and 4 designated connection ports. | Not identical.
Although the number of connection ports is different from the predicate device, both the subject and predicate devices comply with IEC 60601-1 and IEC 60601-2-10 requirements and the difference doesn't impact essential performance, basic safety or substantial equivalence. |
| Dimension Console [W x H x D] Applicator unit [L x D] | 22.4cm W x 41.8cm D x 32.5cm H [8.8'' W x 16.5'' D x 12.8'' H]
Synergy handpiece: 167.5mm L x 43 mm D [6.6'' L x 1.7'' D]
Pro handpiece: 136mm L x 27.5mm D [5.4'' L x 1.1'' D]
Ball type tip: 86mm L x 18mm D [3.4'' L x 0.7'' D]
T type tip: 80mm L x 50mm D [3.1'' L x 2.0'' D]
COMB type tip: 88mm L x 30mm D [3.5'' L x 1.2'' D] | 46cm W x 46cm D x 100cm H [18.2'' W x 18.2'' D x 44'' H]
T3 Applicator unit: 67.3mm L x 54.3mm D [2.7'' L x2.2'' D] | 46cm W x 46cm D x 100cm H [18.2'' W x 18.2'' D x 44'' H]
Tone Applicator: 12cm L x 10cm D [4.7'' L x 4'' D] | Not identical.
Although the dimension of the subject device is different from the predicate device, both the subject and predicate devices comply with IEC 60601-1 and IEC 60601-2-10 requirements, which ensures that they meet the necessary safety and performance standards. The difference in dimension does not affect essential performance, basic safety, or substantial equivalence. |
Page 9
| Name | Subject device | Primary Predicate Device | Secondary Predicate device | Comparison |
|---|---|---|---|---|
| Device Name | EVE Synergy(EVE-20M) | EVOLVE System with the T3 Applicator | EVOLVE System with the Tone Applicator | |
| Manufacturer | WEERO Co.,Ltd. | InMode Ltd. | InMode Ltd. | |
| 510(k) No. | K241433 | K210877 | K201285 | |
| Weight Console Weight applicator | 7 kg [15.4 lbs.] |
Synergy handpiece: 0.12 kg [0.26 lbs.]
Pro handpiece: 0.06 kg [ 0.13 lbs.]
Ball type tip: 0.04 kg [ 0.08 lbs.]
T type tip: 0.02 kg [ 0.04 lbs.]
COMB type tip: 0.02 kg [ 0.04 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.] | Not identical.
Although the weight of the subject device is different from the predicate device, both the subject and predicate devices comply with IEC 60601-1 and IEC 60601-2-10 requirements, which ensures that they meet the necessary safety and performance standards. The difference in weight does not affect essential performance, basic safety, or substantial equivalence. |
| Applicator unit treatment area | Synergy handpiece electrode(2ea): 6 cm²
Ball type tip: 10.17 cm²
T type tip: 7.85 cm²
COMB type tip: 28.83 cm² | 6.46 cm² | 12 cm² | Not identical.
However, the difference doesn't raise new questions of safety and effectiveness. |
| Power Source(s) Power Supply Adapter | - Input: 100-240Vac, 50/60Hz, 1.4-0.7A
- Output: 24Vdc, 5A | Main Line Frequency (nominal) 50-60Hz
Input Voltage (nominal) 100-240VAC
Input Current (rms) 4A | Main Line Frequency (nominal) 50-60Hz
Input Voltage (nominal) 100-240VAC
Input Current (rms) 4A | Not identical.
The subject device was tested and is compliant with IEC60601-1 and IEC 60601-2-10. Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence. |
| Method of Line Current Isolation | Independent transformer isolated | Independent transformer isolated | Independent transformer isolated | Identical |
| Electrical Type | Type BF | Type BF | Type BF | Identical |
| Patient Leakage Current – Normal Condition (μA) |