(87 days)
No.
The document describes a medical device that uses ultrasound and electrical muscle stimulation for aesthetic treatments. It explicitly states "Mentions AI, DNN, or ML: Not Found" and does not provide any descriptions of components or functions that would involve an AI model, such as image processing, data analysis for diagnostic purposes, or adaptive learning algorithms. The device functions as a controlled energy delivery system rather than an intelligent processing unit.
No
While the device is intended for aesthetic and muscle-related improvements, the "Intended Use" section explicitly states that the Pure Impact module "is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind." This indicates it's not a therapeutic device.
No
The device description and intended use clearly state that the SofWave System is an aesthetic treatment device designed to improve muscle tone, reduce wrinkles, lift tissue, and treat cellulite and acne scars. It does not mention any diagnostic capabilities, such as identifying, assessing, or monitoring medical conditions.
No
The device is not a software-only medical device because the description explicitly states it consists of hardware components such as a console, applicator with ultrasonic transducers, and an EMS module, which are physical components that generate and deliver energy for treatment. The software controls these physical components but is not the sole component of the medical device.
No.
This device is an aesthetic treatment system (ultrasound and EMS) that acts on tissues for improvement of appearance and muscle performance. It does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of Acne Scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.
The Pure Impact module is indicated to be used for:
- Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
- Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
- The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training.
Product codes
NGX, OHV
Device Description
The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage.
The SofWave System consists of three main functional components: 1) the console; 2) the applicator; and 3) EMS Module (Pure Impact). The console includes the power sources, cooling unit, electrical components, IoT, BLE, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves at 10-12 MHz and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console. The EMS module is wirelessly connected to and controlled by the SofWave console. It functions independently from the ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Facial lines and wrinkles, eyebrow, submental (beneath the chin) and neck tissue, areas with cellulite, areas with acne scars, upper arms, abdominal, arms, thighs, and buttocks.
Indicated Patient Age Range
subjects aged 22 and older.
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)
The following nonclinical performance testing has been conducted to support the performance of the SofWave System. In all instances, the subject SofWave System performed as intended.
- Software verification and validation was performed, and demonstrated that the software performs as intended;
- Electrical Safety and Electromagnetic Compatibility was established in accordance with IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, IEC 60601-2-10, and IEC 60601-2-62;
- Functional bench testing was conducted to verify the minor device modifications did not affect the device performance.
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 - SofWave System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 18, 2025
Sofwave Medical Ltd.
℅ Janice Hogan
Partner
Hogan Lovells US LLP
1735 Market Street, Suite 2300
Philadelphia, Pennsylvania 19312
Re: K250146
Trade/Device Name: SofWave System
Regulation Number: 21 CFR 890.5850
Regulation Name: Powered Muscle Stimulator
Regulatory Class: Class II
Product Code: NGX, OHV
Dated: January 20, 2025
Received: January 21, 2025
Dear Janice Hogan:
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
K250146 - Janice Hogan 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
K250146 - Janice Hogan Page 3
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
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): K250146
Device Name: SofWave System
Indications for Use (Describe)
The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of Acne Scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.
The Pure Impact module is indicated to be used for:
- Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
- Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
- The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training.
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:
Department of Health and Human Services
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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
K250146 510(k) SUMMARY
Sofwave Medical's SofWave System
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
Sofwave Medical Ltd.
1 Ha-Otsma St.
Yokneam Ilit,
Israel 2069200
Contact Person:
Ruthie Amir, MD, Chief Medical Officer
ruthie@sofwave.com
+972543003164
Date Prepared: March 20, 2025
Name of Device:
SofWave System
Classification Name:
21 CFR 890.5850 (Powered Muscle Stimulator), Class II, product code NGX
21 CFR 878.4590 (Focused Ultrasound Stimulator System for Aesthetic Use), Class II, product code OHV
Predicate Devices
- Sofwave Medical's SofWave System (K241685, K233104) (Predicate Device)
- XBody Hungary Kft.'s XBody Go USA, XBody Pro USA (K221200) (Predicate Device)
- DJO LLC's Compex Wireless USA (K143551) (Reference Device)
Intended Use / Indications for Use
The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of Acne Scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.
The Pure Impact module is indicated to be used for:
Page 6
- Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
- Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
- The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training.
Technological Characteristics
The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage.
The SofWave System consists of three main functional components: 1) the console; 2) the applicator; and 3) EMS Module (Pure Impact). The console includes the power sources, cooling unit, electrical components, IoT, BLE, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves at 10-12 MHz and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console. The EMS module is wirelessly connected to and controlled by the SofWave console. It functions independently from the ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.
Comparison with the Predicate Devices
The indications for use statement for the subject device is similar to the indications for use of the previously cleared SofWave device in K241685. Regarding the SofWave module, the indications for use statement now reflects both previously cleared indications in K241685 and the indications for acne scars and skin laxity on the upper arms, which were cleared in K233104. Regarding the Pure Impact module, the additional indication for muscle training is identical to the language used in the XBody predicate (K221200).
The SofWave module is almost identical to the previous SofWave device that was cleared in K241685, other than a few minor changes made to the hardware of the cleared device. These minor modifications do not change the treatment parameters or energy specification, nor do they present any new questions of safety or effectiveness.
The subject Pure Impact module is very similar to the predicate SofWave device that was cleared in K241685. No hardware changes were made to the cleared SofWave device's Pure Impact module. The software has been updated to allow the additional indication for muscle training. The Pure Impact module also has similar technology to the XBody predicate device (K221200). Both devices are electrical muscle stimulators that generate electrical pulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. Both devices contract muscles rhythmically to improve or facilitate muscle performance. Both the Pure Impact module of SofWave system and XBody consist of a console with a touchscreen control panel and
Page 7
wireless, lithium battery-powered stimulation modules. For both devices, all system functions are controlled through the console. During a treatment session, electrical stimulation is delivered to the treatment area at the selected treatment mode and intensity.
The minor differences in the subject device's technological characteristics compared to the predicate devices do not raise different questions of safety or effectiveness.
Table 1: Substantial Equivalence Chart – SofWave Module
| Subject Device K250146 | Predicate Device K241685 | |
|---|---|---|
| Product | SofWave (SofWave Module) | SofWave (SofWave Module) |
| Regulation | 21 CFR 878.4590 | 21 CFR 878.4590 |
| Product Code | OHV | OHV |
| Indications | The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of Acne Scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms. | The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of Acne Scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms. (Cleared in K233104) |
| Technology | High Intensity non-focused Ultrasound | High Intensity non-focused Ultrasound |
| System Components | • Console that includes the power sources, electrical components and user interface (touchscreen) | |
| • Handpiece | • Console that includes the power sources, electrical components and user interface (touchscreen) | |
| • Handpiece | ||
| Energy Delivered per PZT | 3-5 Joule per PZT (Lift and Precise applicators) | |
| 2.6-7 Joule per PZT (Smooth/LiftHD applicator) | 3-5 Joule per PZT (Lift and Precise applicators) | |
| 2.6-7 Joule per PZT (Smooth/LiftHD applicator) | ||
| Epidermal Impact | Non-invasive | Non-invasive |
| Treatment Area | 15, 35, or 70 mm² | 15, 35, or 70 mm² |
| User Interface | LCD Touch Screen Graphic User Interface | LCD Touch Screen Graphic User Interface |
Page 8
Table 2: Substantial Equivalence Chart – Pure Impact Module
| Subject Device (K250146) | Predicate Device (K241685) | Predicate Device (K221200) | Reference Device (K143551) | |
|---|---|---|---|---|
| Product | SofWave (Pure Impact Module) | SofWave (Pure Impact Module) | XBODY Go USA and XBODY Pro USA | Compex Wireless USA |
| Regulation Number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 |
| Classification Name | Powered muscle stimulator | Powered muscle stimulator | Powered muscle stimulator | Powered muscle stimulator |
| Product Code | NGX | NGX | NGX | NGX |
| Indications for Use | The Pure Impact module is indicated to be used for: | |||
| • Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. | ||||
| • Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas. | ||||
| • The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training. | The Pure Impact module is indicated to be used for: | |||
| • Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. | ||||
| • Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas. | • The XBODY Go USA and XBODY Pro USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes. | |||
| • The XBODY Go USA and XBODY Pro USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the XBODY Go USA and XBODY Pro USA training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. | ||||
| • The XBODY Go USA and XBODY Pro USA electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle | • The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy. The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different |
Page 9
| Subject Device (K250146) | Predicate Device (K241685) | Predicate Device (K221200) | Reference Device (K143551) | |
|---|---|---|---|---|
| Product | SofWave (Pure Impact Module) | SofWave (Pure Impact Module) | XBODY Go USA and XBODY Pro USA | Compex Wireless USA |
| fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. | ||||
| • The various types of muscle work that the XBODY Go USA and XBODY Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA may therefore be considered a technique of muscle training. | types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training. | |||
| Power Source | Console Power source: 100-240AC, 50/60Hz | |||
| Rechargeable Lithium Ion Polymer Battery Pack 3.7 V | ||||
| Nominal Voltage: 3.7V | ||||
| Nominal Capacity: 600mA | Console Power source: 100-240AC, 50/60Hz | |||
| Rechargeable Lithium Ion Polymer Battery Pack 3.7 V | ||||
| Nominal Voltage: 3.7V | ||||
| Nominal Capacity: 600mA | Li-ion Battery 4x 3.7V (3.4 Ah) | |||
| Remote: Lithium Polymer (LiPo) rechargeable 3.7[V] / ≥ 1500[mAh] | ||||
| Stimulation Modules: Lithium Polymer (LiPo) rechargeable 3.7[V] / ≥ 450[mAh] | ||||
| Patient Leakage Current - Normal Condition | Normal condition = less than 100µA | Normal condition = less than 100µA | N/A | N/A |
| Display | Touch screen LCD | Touch screen LCD | Touch screen LCD | LCD |
| Number of Output Channels | Maximum of 6 channels per treatment (up to 2 on each body area) | Maximum of 4 channels per treatment (up to 2 on each body area) | 6 output channels, but 12 independently regulated outputs | 4 channels |
| Method of Channel Isolation | Separate units for pulse generation (wireless units). Line power is NA | Separate units for pulse generation (wireless units). Line power is NA | N/A | N/A |
| Regulated Current or Regulated Voltage | Regulated current | Regulated current | Regulated voltage | Regulated current |
Page 10
| Subject Device (K250146) | Predicate Device (K241685) | Predicate Device (K221200) | Reference Device (K143551) | |
|---|---|---|---|---|
| Product | SofWave (Pure Impact Module) | SofWave (Pure Impact Module) | XBODY Go USA and XBODY Pro USA | Compex Wireless USA |
| Software/Firmware/Microprocessors Controls? | Yes | Yes | Overload trip detects short-circuit, No-load trip detects circuit break, battery voltage monitoring, hardware error detection at startup, and watchdog monitoring. | Yes |
| Automatic Overload Trip? | Yes | Yes | Yes | Yes |
| Automatic No-Load Trip | Yes | Yes | Yes | Yes |
| Automatic Shut off? | Yes | Yes | Yes | Yes |
| Patient Override Control? | Yes | Yes | Yes | Yes |
| Indicator Display: On/Off Status? | Yes | Yes | N/A | Yes |
| Low Battery? | Yes | Yes | N/A | Yes |
| Voltage/Current Level? | Yes (Energy level) | Yes (Energy level) | N/A | Yes (Energy level) |
| Timer Range (minutes) | Up to 60 minutes | Up to 60 minutes | N/A | Up to 48 minutes |
| Compliance with Voluntary Standards? | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, and ISO14971 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, and ISO14971 | IEC 60529, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 62304, IEC 62366-1 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 62304, IEC 62366, and ISO14971 |
| Compliance With 21 CFR 898 | Yes, the electrode cable can never be plugged in the AC socket, not even accidentally | Yes, the electrode cable can never be plugged in the AC socket, not even accidentally | N/A | Yes. |
| Housing Material and Construction | PCABS510 for console covers & end point shells | PCABS510 for console covers & end point shells | Plastic | N/A |
Notably, the subject Pure Impact module has very similar output waveform specifications as the XBody predicate device and the Compex reference device. All parameters are similar between the devices. Differences are minor and not clinically relevant.
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Table 3: Comparison of Waveform Specifications
| Subject Device (K250146) | SofWave Pure Impact (K241685) | XBody (K221200) | Compex Wireless Reference Device (K143551) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Basic | Focused | Enhanced | PlyoPulse | Basic | Focused | Enhanced | PlyoPulse | |||
| Waveform | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical biphasic |
| Shape | Square wave | Square wave | Square wave | Square wave | Square wave | Square wave | Square wave | Square wave | Rectangular | Rectangular |
| Maximum Output Voltage | 51 Vpp @ 500 Ω (± 10%) | 51 Vpp @ 500 Ω (± 10%) | 51 Vpp @ 500 Ω (± 10%) | 51 Vpp @ 500 Ω (± 10%) | 51 Vpp @ 500 Ω (± 10%) | 51 Vpp @ 500 Ω (± 10%) | 51 Vpp @ 500 Ω (± 10%) | 51 Vpp @ 500 Ω (± 10%) | 20.8V @ 500Ω | 60 Vpp @ 500 Ω (± 10%) |
| 204 Vpp @ 2 kΩ (± 10%) | 204 Vpp @ 2 kΩ (± 10%) | 204 Vpp @ 2 kΩ (± 10%) | 204 Vpp @ 2 kΩ (± 10%) | 204 Vpp @ 2 kΩ (± 10%) | 204 Vpp @ 2 kΩ (± 10%) | 204 Vpp @ 2 kΩ (± 10%) | 204 Vpp @ 2 kΩ (± 10%) | 180 Vpp @ 2 kΩ (± 10%) | ||
| 228 Vpp @ 10 kΩ (± 10%) | 228 Vpp @ 10 kΩ (± 10%) | 228 Vpp @ 10 kΩ (± 10%) | 228 Vpp @ 10 kΩ (± 10%) | 228 Vpp @ 10 kΩ (± 10%) | 228 Vpp @ 10 kΩ (± 10%) | 228 Vpp @ 10 kΩ (± 10%) | 228 Vpp @ 10 kΩ (± 10%) | 180 Vpp @ 10 kΩ (± 10%) | ||
| Maximum Output Current | 102 mA pp @ 500 Ω (± 10%) | 102 mA pp @ 500 Ω (± 10%) | 102 mA pp @ 500 Ω (± 10%) | 102 mA pp @ 500 Ω (± 10%) | 102 mA pp @ 500 Ω (± 10%) | 102 mA pp @ 500 Ω (± 10%) | 102 mA pp @ 500 Ω (± 10%) | 102 mA pp @ 500 Ω (± 10%) | 41.6 mA @ 500Ω | 120 mA pp @ 500 Ω |
| 102 mA pp @ 2 kΩ (± 10%) | 102 mA pp @ 2 kΩ (± 10%) | 102 mA pp @ 2 kΩ (± 10%) | 102 mA pp @ 2 kΩ (± 10%) | 102 mA pp @ 2 kΩ (± 10%) | 102 mA pp @ 2 kΩ (± 10%) | 102 mA pp @ 2 kΩ (± 10%) | 102 mA pp @ 2 kΩ (± 10%) | 90 mA pp @ 2 kΩ | ||
| 22 mA pp@ 10 kΩ (± 10%) | 22 mA pp@ 10 kΩ (± 10%) | 22 mA pp@ 10 kΩ (± 10%) | 22 mA pp@ 10 kΩ (± 10%) | 22 mA pp@ 10 kΩ (± 10%) | 22 mA pp@ 10 kΩ (± 10%) | 22 mA pp@ 10 kΩ (± 10%) | 22 mA pp@ 10 kΩ (± 10%) | 18 mA pp @ 10 kΩ | ||
| Pulse Width | 50 to 500 µS (± 10%) @500Ω | 50 to 500 µS (± 10%) @500Ω | 50 to 500 µS (± 10%) @500Ω | 50 to 500 µS (± 10%) @500Ω | 250 to 350 µS (± 10%) @500Ω | 150 to 350 µS (± 10%) @500Ω | 150 to 350 µS (± 10%) @500Ω | 150 to 350 µS (± 10%) @500Ω | 50-500 μS | 300 to 400 µS |
| Frequency | 1-150Hz @ 500Ω | 1-150Hz @ 500Ω | 1-150Hz @ 500Ω | 1-150Hz @ 500Ω | 1-100Hz @ 500Ω | 1-100Hz @ 500Ω | 1-100Hz @ 500Ω | 1-100Hz @ 500Ω | 1‐150 Hz | 1 to 120 Hz |
| For Multiphasic Waveform Symmetrical Phases? | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic | Yes, Symmetrical Biphasic |
| Number of Output Channels | 6 | 6 | 6 | 6 | 4 | 4 | 4 | 4 | 6 | 4 |
| Net Charge | 0 uC @500Ω (Being Biphasic in nature the net charge would be Zero) | 0 uC @500Ω (Being Biphasic in nature the net charge would be Zero) | 0 uC @500Ω (Being Biphasic in nature the net charge would be Zero) | 0 uC @500Ω (Being Biphasic in nature the net charge would be Zero) | 0 uC @500Ω (Being Biphasic in nature the net charge would be Zero) | 0 uC @500Ω (Being Biphasic in nature the net charge would be Zero) | 0 uC @500Ω (Being Biphasic in nature the net charge would be Zero) | 0 uC @500Ω (Being Biphasic in nature the net charge would be Zero) | 0 μC @ 500Ω (each phase uses symmetric waveform) | 0 µC @ 500Ω Excitation pulse fully compensated |
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| Subject Device (K250146) | SofWave Pure Impact (K241685) | XBody (K221200) | Compex Wireless Reference Device (K143551) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Basic | Focused | Enhanced | PlyoPulse | Basic | Focused | Enhanced | PlyoPulse | |||
| Maximum Phase Charge | 17.85 µC @ 500Ω | 17.85 µC @ 500Ω | 17.85 µC @ 500Ω | 17.85 µC @ 500Ω | 17.85 µC @ 500Ω | 17.85 µC @ 500Ω | 17.85 µC @ 500Ω | 17.85 µC @ 500Ω | 16.64 µC @ 500Ω | 48 µC @ 500Ω |
| Maximum Current Density | 2.0 mA/cm² @ 500Ω | 2.0 mA/cm² @ 500Ω | 2.0 mA/cm² @ 500Ω | 2.0 mA/cm² @ 500Ω | 2.0 mA/cm² @ 500Ω | 2.0 mA/cm² @ 500Ω | 2.0 mA/cm² @ 500Ω | 2.0 mA/cm² @ 500Ω | 0.65mA/cm² @500Ω | 1.49 mA/cm² @ 500Ω |
| *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | N/A | N/A | |
| Maximum Power Density | 0.052 Watt/cm² @ 500Ω Load | 0.052 Watt/cm² @ 500Ω Load | 0.052 Watt/cm² @ 500Ω Load | 0.052 Watt/cm² @ 500Ω Load | 0.052 Watt/cm² @ 500Ω Load | 0.052 Watt/cm² @ 500Ω Load | 0.052 Watt/cm² @ 500Ω Load | 0.052 Watt/cm² @ 500Ω Load | 3.46mW/cm² @500Ω | 27.6 mW/cm² @500Ω |
| *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | *measured with 50 x 50mm rectangular electrodes | N/A | N/A | |
| Burst Mode | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | Yes | NA |
| ON Time | 1 - 12 seconds | 1 - 12 seconds | 1 - 12 seconds | 1 - 12 seconds | 6 seconds | 6 seconds | 6 seconds | 4 - 12 seconds | 10 seconds | NA |
| OFF Time | 1 - 6 seconds | 1 - 6 seconds | 1 - 6 seconds | 1 - 6 seconds | 4 seconds | 4 seconds | 4 seconds | 2 - 6 seconds | 1 seconds | NA |
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Performance Data
The following nonclinical performance testing has been conducted to support the performance of the SofWave System. In all instances, the subject SofWave System performed as intended.
- Software verification and validation was performed, and demonstrated that the software performs as intended;
- Electrical Safety and Electromagnetic Compatibility was established in accordance with IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, IEC 60601-2-10, and IEC 60601-2-62;
- Functional bench testing was conducted to verify the minor device modifications did not affect the device performance.
Clinical Summary
No clinical test data was required to support substantial equivalence.
Conclusion
The subject device and its predicate have the same intended use and similar indications, technological characteristics and principles of operation. Moreover, the minor differences in the technological characteristics do not present different questions of safety or effectiveness as compared to the predicate device. Performance testing demonstrates that the subject device is as safe and effective as its predicate device. Thus, the SofWave is substantially equivalent to its predicate device.