SofWave System

K241685 · Sofwave Medical, Ltd. · NGX · Aug 7, 2024 · Physical Medicine

Device Facts

• Record ID: K241685
• Device Name: SofWave System
• Applicant: Sofwave Medical, Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Aug 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SofMave 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 indicated for short-term improvement in the appearance of cellulite. 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.

Device Story

System comprises console, ultrasound applicator, and wireless Electrical Muscle Stimulation (EMS) module (Pure Impact). Ultrasound component emits 10-12 MHz acoustic waves to heat dermis for aesthetic treatment; EMS component delivers electrical impulses via skin electrodes to induce rhythmic muscle contractions. Operated by clinician in clinic setting. Console features touchscreen for mode selection (ultrasound or EMS, not simultaneous) and intensity control. Output affects tissue via thermal damage (ultrasound) or muscle strengthening/toning (EMS). Benefits include improved skin appearance and muscle tone.

Clinical Evidence

No clinical test data was used to support the decision of substantial equivalence. Bench testing and software verification testing were performed.

Technological Characteristics

System includes console (power, cooling, IoT/BLE, UI), ultrasound applicator (transducer array, 10-12 MHz), and wireless EMS module. Materials: PCABS510 for console covers/shells. EMS delivers symmetrical biphasic square wave pulses. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971. Connectivity: Wireless between console and EMS module.

Indications for Use

Indicated for subjects aged 22+ for non-invasive aesthetic treatment of facial lines/wrinkles, eyebrow lifting, and lifting lax submental/neck tissue. Also indicated for short-term improvement in cellulite appearance. Pure Impact module indicated for strengthening abdominal muscles, improving abdominal tone/firmness, and strengthening/toning muscles in arms, thighs, and buttocks.

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

• SofWave System (K240687)
• Mettler Electronics Corporation accufit (K233926)

Reference Devices

• HIVOX Spopad EMS SP-911, SP-921 (K192264)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 7, 2024

Sofwave Medical Ltd. Ruthie Amir Chief Medical Officer 1 Ha-Otsma St. Yokneam Ilit, 2069200 Israel

Re: K241685

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: June 11, 2024 Received: June 11, 2024

Dear Ruthie Amir:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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).

Sincerely.

# Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices

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Enclosure

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## Indications for Use

Submission Number (if known)

K241685

Device Name

SofWave System

Indications for Use (Describe)

The SofMave 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 indicated for short-term improvement in the appearance of cellulite.

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) SUMMARY

#### Sofwave Medical's SofWave System, K241685

#### 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 [e-mail] [phone]

Date Prepared: June 11, 2024

#### 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 (K240687) (Predicate Device)

Mettler Electronics Corporation's accufit (K233926) (Predicate Device)

Hivox Biotek Inc.'s HIVOX Spopad EMS SP-911, SP-921 (K192264) (Reference Device)

#### Intended Use / Indications for Use

The SofMave 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 indicated for short-term improvement in the appearance of cellulite.

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.

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#### 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 SofMave System consists of three main functional components: 1) console: 2) applicator: and 3) Electrical Muscle Stimulation (EMS) Module (Pure Impact). The console includes 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 of Technological Characteristics with the Predicate Devices

The SofWave module is almost identical to the previous SoftWave device that was cleared in K240687, 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 SofMave device that was cleared in K240687. No hardware changes were made to the cleared SofWave device's Pure Impact module. The software has been updated to allow the previously cleared plyometric protocol to arms. The Pure Impact module also has similar technology to the accufit predicate device (K233926). Both devices are electrical muscle stimulators that generate electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. Both devices contract muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the arms, thighs, and buttocks. Both the Pure Impact module of SofMave system and accufit consist of a console with a touchscreen control panel and power supply module. For both devices, all system functions are controlled through the console. During a treatment session, one or more electrodes are secured to the patient, and 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.

| | Subject Device | Predicate Device K240687 |
|---------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Product | SofWave (SofWave Module) | SofWave (SofWave Module) |
| Regulation Number | 21 CFR 878.4590 | 21 CFR 878.4590 |
| Product Code | OHV | OHV |
| Indications for Use | The SofWave System is indicated for<br>use as a non-invasive dermatological<br>aesthetic treatment to improve facial | The SofWave System is indicated for<br>use as a non-invasive dermatological<br>aesthetic treatment to improve facial |

Table 1: Substantial Equivalence Chart - SofWave Module

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| | Subject Device | Predicate Device K240687 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | SofWave (SofWave Module) | SofWave (SofWave Module) |
| | lines and wrinkles, lift the eyebrow,<br>and lift lax submental (beneath the<br>chin) and neck tissue; which can also<br>affect the appearance of lax tissue in<br>the submental and neck regions for<br>subjects aged 22 and older. The<br>SofWave System is also intended for<br>short-term improvement in the<br>appearance of cellulite. | lines and wrinkles, lift the eyebrow,<br>and lift lax submental (beneath the<br>chin) and neck tissue; which can also<br>affect the appearance of lax tissue in<br>the submental and neck regions for<br>subjects aged 22 and older. The<br>SofWave System is also intended for<br>short-term improvement in the<br>appearance of cellulite. |
| Device Technology | High Intensity non-focused<br>Ultrasound | High Intensity non-focused<br>Ultrasound |
| System Components | Console that includes the power<br>sources, electrical components<br>and user interface (touchscreen) Handpiece | Console that includes the power<br>sources, electrical components<br>and user interface (touchscreen) Handpiece |
| Energy Delivered per<br>PZT | 3-5 Joule per PZT (Lift and Precise<br>applicators)<br><br>2.6-7 Joule per PZT (Smooth<br>applicator) | 3-5 Joule per PZT (Lift and Precise<br>applicators)<br><br>2.6-7 Joule per PZT (Smooth<br>applicator) |
| Epidermal Impact | Non-invasive | Non-invasive |
| Treatment Area | $15, 35, or 70 mm^2$ | $15, 35, or 70 mm^2$ |
| User Interface | LCD Touch Screen Graphic User<br>Interface | LCD Touch Screen Graphic User<br>Interface |

### Table 2: Substantial Equivalence Chart – Pure Impact Module

| | Subject Device | Predicate Device<br>(K240687) | Predicate Device<br>(K233926) |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | SofWave (Pure Impact<br>Module) | SofWave (Pure Impact<br>Module) | accufit |
| Regulation Number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 |
| Classification Name | Powered muscle<br>stimulator | Powered muscle<br>stimulator | Powered muscle<br>stimulator |
| Product Code | NGX | NGX | NGX |
| Indication for Use | indicated to be used<br>for:<br>• Improvement of<br>abdominal tone, for<br>strengthening of the<br>abdominal muscles,<br>for development of<br>firmer abdomen. | indicated to be used<br>for:<br>• Improvement of<br>abdominal tone, for<br>strengthening of the<br>abdominal muscles,<br>for development of<br>firmer abdomen. | • Relaxation of<br>muscle spasms<br>• Prevention or<br>retardation of<br>disuse atrophy<br>• Increase local blood<br>circulation. |
| | Subject Device | Predicate Device<br>(K240687) | Predicate Device<br>(K233926) |
| Product | SofWave (Pure Impact<br>Module) | SofWave (Pure Impact<br>Module) | accufit |
| | Improvement of<br>muscle tone and<br>firmness, for<br>strengthening<br>muscles in arms,<br>thighs and buttocks<br>areas. | Strengthening,<br>toning and firming<br>of buttocks and<br>thighs. | Muscle re-<br>education Maintaining or<br>increasing range of<br>motion Immediate<br>postsurgical<br>stimulation of calf<br>muscles to prevent<br>venous thrombosis Improvement of<br>abdominal tone, for<br>strengthening of the<br>abdominal muscles,<br>for development of<br>firmer abdomen. Improvement of<br>muscle tone and<br>firmness, for<br>strengthening<br>muscles in arms,<br>thighs and buttocks<br>areas |
| Power Source | Console Power source:<br>100-240AC, 50/60Hz<br><br>Rechargeable Lithium<br>Ion Polymer Battery<br>Pack 3.7 V<br>Nominal Voltage: 3.7V<br>Nominal Capacity:<br>600mA | Console Power source:<br>100-240AC, 50/60Hz<br><br>Rechargeable Lithium<br>Ion Polymer Battery<br>Pack 3.7 V<br>Nominal Voltage: 3.7V<br>Nominal Capacity:<br>600mA | 100-240VAC ,<br>50/60Hz, 1.0A (Fuse:<br>250V / 6.3A) |
| Patient Leakage<br>Current - Normal<br>Condition | Normal condition = less<br>than 100μA | Normal condition = less<br>than 100μA | Less than 100μA |
| Display | Touch screen LCD | Touch screen LCD | Touch screen LCD |
| Number of Output<br>Channels | Maximum of 4 channels<br>per treatment (up to 2<br>on arms) | Maximum of 4 channels<br>per treatment | 2 |
| Method of Channel<br>Isolation | Separate units for pulse<br>generation (wireless<br>units). Line power is NA | Separate units for pulse<br>generation (wireless<br>units). Line power is NA | Double insulated wire<br>non- conductive<br>enclosure |
| Regulated Current or<br>Regulated Voltage | Regulated current | Regulated current (all<br>channels) | Regulated current |
| | Subject Device | Predicate Device<br>(K240687) | Predicate Device<br>(K233926) |
| Product | SofWave (Pure Impact<br>Module) | SofWave (Pure Impact<br>Module) | accufit |
| Software / Firmware /<br>Microprocessors<br>Controls? | Yes | Yes | Yes |
| Automatic Overload<br>Trip? | Yes | Yes | Yes |
| Automatic No-Load Trip | Yes | Yes | Yes |
| Automatic Shut off? | Yes | Yes | Yes |
| Patient Override<br>Control? | Yes | Yes | Yes |
| Indicator Display:<br>On/Off Status? | Yes | Yes | Yes |
| Low Battery? | Yes | Yes | Yes |
| Voltage/Current Level? | Yes (Energy level) | Yes (Energy level) | Yes |
| Timer Range (minutes) | Up to 60 minutes | Up to 60 minutes | 13, 30, 45 minutes |
| Compliance with<br>Voluntary Standards | IEC 60601-1, IEC<br>60601-1-2, IEC 60601-<br>2-10, ISO 14971 | IEC 60601-1, IEC<br>60601-1-2, IEC 60601-<br>2-10, ISO 14971 | IEC 60601-1, IEC<br>60601-1-2, IEC 60601-<br>2-10, ISO 14971, UL<br>60601, CSA C22.2 No<br>606.1 |
| Compliance With 21<br>CFR 898 | Yes, the electrode<br>cable can never be<br>plugged in the AC<br>socket, not even<br>accidentally | Yes, the electrode<br>cable can never be<br>plugged in the AC<br>socket, not even<br>accidentally | Yes |
| Housing Material and<br>Construction | PCABS510 for console<br>covers & end point<br>shells | PCABS510 for console<br>covers & end point<br>shells | ABS plastic |

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Notably, the subject Pure Impact module has very similar output waveform specifications as the accufit predicate device and the HIVOX reference device. As shown in the detailed comparison below, 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 | | | | SofWave Pure Impact (K240687) | | | | accufit<br>(K233926) | HIVOX<br>(K192264) |
|----------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|----------------------------|----------------------------------------------------|
| | Basic | Focused | Enhanced | PlyoPulse | Basic | Focused | Enhanced | PlyoPulse | | |
| Waveform | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic | Not publicly<br>available. | Symmetrical<br>biphasic |
| Shape | Square wave | Square wave | Square wave | Square wave | Square wave | Square wave | Square wave | Square wave | Not publicly<br>available. | Rectangular |
| | 51 Vpp @<br>500 Ω (±<br>10%) | 51 Vpp @<br>500 Ω (±<br>10%) | 51 Vpp @<br>500 Ω (±<br>10%) | 51 Vpp @<br>500 Ω (±<br>10%) | 51 Vpp @<br>500 Ω (±<br>10%) | 51 Vpp @<br>500 Ω (±<br>10%) | 51 Vpp @<br>500 Ω (±<br>10%) | 51 Vpp @<br>500 Ω (±<br>10%) | Not publicly<br>available. | 52-58.4 Vpp @<br>500Ω; |
| Maximum<br>Output<br>Voltage | 204 Vpp @ 2<br>kΩ (± 10%) | 204 Vpp @ 2<br>kΩ (± 10%) | 204 Vpp @ 2<br>kΩ (± 10%) | 204 Vpp @ 2<br>kΩ (± 10%) | 204 Vpp @ 2<br>kΩ (± 10%) | 204 Vpp @ 2<br>kΩ (± 10%) | 204 Vpp @ 2<br>kΩ (± 10%) | 204 Vpp @ 2<br>kΩ (± 10%) | Not publicly<br>available | 102-106<br>Vpp @ 2kΩ |
| | 228 Vpp @<br>10 kΩ (±<br>10%) | 228 Vpp @<br>10 kΩ (±<br>10%) | 228 Vpp @<br>10 kΩ (±<br>10%) | 228 Vpp @<br>10 kΩ (±<br>10%) | 228 Vpp @<br>10 kΩ (±<br>10%) | 228 Vpp @<br>10 kΩ (±<br>10%) | 228 Vpp @<br>10 kΩ (±<br>10%) | 228 Vpp @<br>10 kΩ (±<br>10%) | Not publicly<br>available. | 150-154<br>Vpp @ 10kΩ |
| Maximum<br>Output<br>Current | 102 mA pp @<br>500 Ω (± 10%) | 102 mA pp @<br>500 Ω (± 10%) | 102 mA pp @<br>500 Ω (± 10%) | 102 mA pp @<br>500 Ω (± 10%) | 102 mA pp @<br>500 Ω (± 10%) | 102 mA pp @<br>500 Ω (± 10%) | 102 mA pp @<br>500 Ω (± 10%) | 102 mA pp @<br>500 Ω (± 10%) | Not publicly<br>available. | 104-117 mA pp<br>@ 500Ω (±<br>20%) |
| | 102 mA pp @<br>2 kΩ (± 10%) | 102 mA pp @<br>2 kΩ (± 10%) | 102 mA pp @<br>2 kΩ (± 10%) | 102 mA pp @<br>2 kΩ (± 10%) | 102 mA pp @<br>2 kΩ (± 10%) | 102 mA pp @<br>2 kΩ (± 10%) | 102 mA pp @<br>2 kΩ (± 10%) | 102 mA pp @<br>2 kΩ (± 10%) | Not publicly<br>available | 51-53 mA pp @<br>2kΩ (± 20%) |
| | 22 mA pp@<br>10 kΩ (± 10%) | 22 mA pp@<br>10 kΩ (± 10%) | 22 mA pp@<br>10 kΩ (± 10%) | 22 mA pp@<br>10 kΩ (± 10%) | 22 mA pp@<br>10 kΩ (± 10%) | 22 mA pp@<br>10 kΩ (± 10%) | 22 mA pp@<br>10 kΩ (± 10%) | 22 mA pp@<br>10 kΩ (± 10%) | Not publicly<br>available. | 15-15.4 mA pp<br>@ 10kΩ-15.4 (±<br>20%) |
| Pulse Width | 250 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | 250 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | Not publicly<br>available. | 400 µSec |
| Frequency | 1-100Hz @<br>500Ω | 1-100Hz @<br>500Ω | 1-100Hz @<br>500Ω | 1-100Hz @<br>500Ω | 1-100Hz @<br>500Ω | 1-100Hz @<br>500Ω | 1-100Hz @<br>500Ω | 1-100Hz @<br>500Ω | Not publicly<br>available. | 2-25 Hz |
| For<br>multiphasic<br>Waveform<br>Symmetrical<br>Phases? | Yes,<br>Symmetrical<br>Biphasic | Yes,<br>Symmetrical<br>Biphasic | Yes,<br>Symmetrical<br>Biphasic | Yes,<br>Symmetrical<br>Biphasic | Yes,<br>Symmetrical<br>Biphasic | Yes,<br>Symmetrical<br>Biphasic | Yes,<br>Symmetrical<br>Biphasic | Yes,<br>Symmetrical<br>Biphasic | Not publicly<br>available. | Not publicly<br>available. |
| Phase<br>duration | 250 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | 250 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | Not publicly<br>available. | N/A |
| Net charge | 0 uC @500Ω<br>(Being<br>Biphasic in | 0 uC @500Ω<br>(Being<br>Biphasic in | 0 uC @500Ω<br>(Being<br>Biphasic in | 0 uC @500Ω<br>(Being<br>Biphasic in | 0 uC @500Ω<br>(Being<br>Biphasic in | 0 uC @500Ω<br>(Being<br>Biphasic in | 0 uC @500Ω<br>(Being<br>Biphasic in | 0 uC @500Ω<br>(Being<br>Biphasic in | Not publicly<br>available. | 0.416-0.468 µC<br>@500Ω |
| | Subject Device | | | | SofWave Pure Impact (K240687) | | | | accufit<br>(K233926) | HIVOX<br>(K192264) |
| | Basic | Focused | Enhanced | PlyoPulse | Basic | Focused | Enhanced | PlyoPulse | | |
| | nature the net<br>charge would<br>be Zero) | nature the net<br>charge would<br>be Zero) | nature the net<br>charge would<br>be Zero) | nature the net<br>charge would<br>be Zero) | nature the net<br>charge would<br>be Zero) | nature the net<br>charge would<br>be Zero) | nature the net<br>charge would<br>be Zero) | nature the net<br>charge would<br>be Zero) | | |
| Maximum<br>Phase Charge | 17.85 µC @<br>500Ω | 17.85 µC @<br>500Ω | 17.85 µC @<br>500Ω | 17.85 µC @<br>500Ω | 17.85 µC @<br>500Ω | 17.85 µC @<br>500Ω | 17.85 µC @<br>500Ω | 17.85 µC @<br>500Ω | Not publicly<br>available. | 41.6-46.8 µC,<br>500 Ω |
| Maximum<br>Current<br>density | 2.0 mA/cm² @<br>500Ω | 2.0 mA/cm² @<br>500Ω | 2.0 mA/cm² @<br>500Ω | 2.0 mA/cm² @<br>500Ω | 2.0 mA/cm² @<br>500Ω | 2.0 mA/cm² @<br>500Ω | 2.0 mA/cm² @<br>500Ω | 2.0 mA/cm² @<br>500Ω | Not publicly<br>available. | 1.057-1.672<br>mA/cm2, 500 Ω |
| | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | Not publicly<br>available. | N/A |
| Maximum<br>Power Density | 0.052<br>Watt/cm² @<br>500Ω Load | 0.052<br>Watt/cm² @<br>500Ω Load | 0.052<br>Watt/cm² @<br>500Ω Load | 0.052<br>Watt/cm² @<br>500Ω Load | 0.052<br>Watt/cm² @<br>500Ω Load | 0.052<br>Watt/cm² @<br>500Ω Load | 0.052<br>Watt/cm² @<br>500Ω Load | 0.052<br>Watt/cm² @<br>500Ω Load | Not publicly<br>available. | 0-0671-0.0869<br>Watt/cm², 500<br>Ω |
| | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | Not publicly<br>available. | N/A |
| Burst Mode | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | Not publicly<br>available. | Yes for one<br>configuration,<br>not for the other |
| ON Time | 6 seconds | 6 seconds | 6 seconds | 4 - 12 seconds | 6 seconds | 6 seconds | 6 seconds | 4 seconds | Not publicly<br>available. | N/A |
| OFF Time | 4 seconds | 4 seconds | 4 seconds | 2 - 6 seconds | 4 seconds | 4 seconds | 4 seconds | 2 seconds | Not publicly<br>available. | N/A |

{10}------------------------------------------------

{11}------------------------------------------------

#### Performance Data

Performance testing, including design verification testing and electrical safety testing, confirmed the minor changes in the SofWave module did not raise different questions. The software modifications were evaluated through software verification testing, which was completed successfully with no major issues found. In all instances, the subject SoftWave System performed as intended.

#### Clinical Summary

No clinical test data was used to support the decision of substantial equivalence.

#### Conclusion

SofWave has the same general intended use and similar indications for use and technological characteristics as the predicate device. The addition of arms to the Pure Impact indications for use and minor technological differences between the subject and the predicate devices do not raise different questions of safety or effectiveness. Performance testing has demonstrated that the device performs as intended. Thus, the SofWave System is substantially equivalent.