Nu Skin RenuSpa iO

K232001 · Nse Products, Inc. · NFO · Nov 21, 2023 · Neurology

Device Facts

• Record ID: K232001
• Device Name: Nu Skin RenuSpa iO
• Applicant: Nse Products, Inc.
• Product Code: NFO · Neurology
• Decision Date: Nov 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nu Skin RenuSpa iO is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

Device Story

Hand-held, portable, rechargeable microcurrent device for aesthetic body skin stimulation; used with conductive gel on thighs, arms, buttocks, and abdomen. Device features four elongated spherical electrodes; internal lithium-ion battery; inductive charging via base. User interface includes single button, seven LED indicators, and audible speaker for feedback (continuous white noise indicates proper skin contact). Device delivers monophasic square wave microcurrent in bursts of 10 positive and 10 negative pulses. Used by consumers at home; treatment duration up to five minutes per area, three days per week. Output parameters (voltage, current, density) are lower than predicate to optimize user experience. Device provides feedback on treatment duration and state via LEDs and audio. Benefits include aesthetic skin toning.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including design verification, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility, and output waveform/energy characteristic evaluations compared to the predicate device.

Technological Characteristics

Hand-held microcurrent stimulator; thermoplastic resin housing; four chrome-plated elongated spherical electrodes. Powered by internal 750 mAh lithium-ion battery; inductive charging. Output: monophasic square wave, 8.3 Hz, 60 ms pulse width. Connectivity: USB-A inductive charger. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, IEC 62366, IEC 60601-1-11, ISO 14971.

Indications for Use

Indicated for over-the-counter cosmetic body skin stimulation on healthy, unbroken skin (excluding face) in adults.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• NuBODY Skin Toning Device (K171588)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

November 21, 2023

NSE Products, Inc % Jack Slovick President Methodize Inc. 24813 Cty 18 Nevis, Minnesota 56467

Re: K232001

Trade/Device Name: Nu Skin RenuSpa iO Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: October 26, 2023 Received: November 1, 2023

Dear Jack Slovick:

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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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 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.

# Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices

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OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K232001

Device Name Nu Skin RenuSpa iO

Indications for Use (Describe)

Nu Skin RenuSpa iO is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

# K232001

This 510(k) Summary was prepared in accordance with 21 CFR 807.92.

#### Date Prepared: 10/26/23

| Submitter/Manufacturer | Nu Skin Enterprises, Inc |
|-----------------------------|------------------------------------------------------------|
| | 75 W. Center St. |
| | Provo, UT 84601 |
| | Establishment Registration # 3001236514 |
| Submission<br>Correspondent | Jack Slovick<br>Regulatory Consultant |
| | Telephone: [phone] |
| | Email: [e-mail] |
| Trade Name | Nu Skin RenuSpa iO |
| Regulation Name | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Regulation Number | 21 CFR 882.5890 |
| Product Code | NFO |
| Device Class | Class II |
| Classification Panel | Division of Neurological and Physical Medicine Devices |
| Predicate Devices | NuBODY Skin Toning Device 510(k)#: K171588 |
| Reason for Submission | New Device |

Note: There were no previous submissions for this device.

#### Device Description

Nu Skin RenuSpa iO is a hand-held, portable, rechargeable microcurrent device used to stimulate certain parts of the body for aesthetic purposes. It is used with a conductive medium. It contains a rechargeable Lithium-ion battery that is recharged with a USBenabled inductive charger.

Nu Skin RenuSpa iO is inductively charged by the supplied Nu Skin RenuSpa iO charging stand. Nu Skin RenuSpa iO is designed to mechanically rest on the charging stand in a manner that ensures proper alignment for charging. The charging stand connects to an external AC/DC USB Power supply adapter via a short length of cable terminated with USB-A Male connection.

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Nu Skin RenuSpa iO is indicated for use only on healthy, unbroken skin.

Nu Skin RenuSpa iQ uses a combination of LED lights and audio feedback.

Nu Skin RenuSpa iO is sold in the United States in a kit with the conductive medium (510k cleared conductive GEL K022006). In all cases the Nu Skin RenuSpa iO and Charger user manual are provided to the user.

#### Product Overview

The Nu Skin RenuSpa iO system (as pictured below) will consist of a topical and handheld device used together approximately once a day, three days a week on thighs, arms, buttocks and/or abdomen. Suggested treatment duration will be up to five minutes for each area. When treatment has concluded, the device should be gently rinsed with warm water and towel dried.

Image /page/5/Picture/5 description: The image shows a medical device. The top portion of the image shows three different views of the device. The bottom portion of the image shows the device sitting on a charger.

Figure 1: Nu Skin RenuSpa iO device and charger

Nu Skin RenuSpa iQ will include an internal (non-removable) lithium-ion battery system that will be charged (inductively) from a low-profile charging base. The user will control

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the device via a single button interface. Seven LED indicator positions and an audible alert speaker system will provide user feedback concerning the state of the device (charge, treatment, duration, etc.).

Image /page/6/Picture/1 description: The image shows a tube of Nu Skin Conductive Gel. The tube is white with gray text. The text on the tube reads "Nu Skin Conductive Gel For external use only 150ml e (5.0 fl.oz.)".

Figure 2: Cleared Conductive Gel

This is an already FDA cleared substance supplied with the kit (K022006).

The Nu Skin RenuSpa iO device contains a rechargeable Lithium-ion battery that is recharged with a USB-enabled inductive charger. Key battery characteristics are shown in the following table:

| Characteristic | Specification |
|-------------------------|------------------|
| Capacity | Typical: 750 mAh |
| Open Circuit Voltage | 3.68~3.92V |
| State of Charge | 50%-80% |
| Weight | 22g |
| Max Voltage | 4.2V |
| Nominal Voltage | 3.6V |
| Fully Discharge Voltage | 3.0V |
| Standard Charge Current | 0.5C |
| Charge time | 3.5 Hours |

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#### Indications for Use.

Nu Skin RenuSpa iO is intended for body skin stimulation and is indicated for over-thecounter cosmetic use.

#### Comparison of Technological Characteristics with the Predicate Device

The Nu Skin RenuSpa iO device is substantially equivalent to the predicate device based on comparison of indications for use and technological characteristics. The indications are identical to that of the predicate device NuBODY Skin Toning Device. There are minor differences but mostly similarities between the subject and the predicate device. These differences will be further explained subsequent to the following table.

| General<br>Comparison Table | Nu Skin RenuSpa iO<br>(New Device) | NuBODY (Predicate) | Remark |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510k # | K232001 | K171588 | N/A |
| Indication | Nu Skin RenuSpa iO is<br>intended for body skin<br>stimulation and is<br>indicated for over-the-<br>counter cosmetic use. | NuBODY Skin Toning<br>Device is intended for<br>body skin stimulation and<br>is indicated for over-the-<br>counter cosmetic use. | Same |
| Anatomic Sites | Areas of the body other<br>than<br>the face | Areas of the body other<br>than<br>the face | Same |
| Technological<br>Characteristics | The Nu Skin RenuSpa iO<br>Device is a body skin<br>toning device. Its outer<br>case is injection molded<br>thermoplastic resin. The<br>output contacts consist of<br>chrome-plated elongated<br>spherical electrodes. The<br>RenuSpa iO device is<br>powered by a<br>rechargeable lithium-ion<br>battery. RenuSpa iO<br>device produces<br>microcurrent that is<br>discharged through four | The NuBODY Skin<br>Toning Device is a body<br>skin toning device. Its<br>outer case is injection<br>molded thermoplastic<br>resin. The output<br>contacts consist of<br>chrome-plated spherical<br>electrodes. The NuBODY<br>device is powered by a<br>rechargeable lithium-ion<br>battery. NuBODY device<br>produces microcurrent<br>that is discharged<br>through four fixed, | Difference<br>Note 1 |
| | fixed, smooth elongated | smooth spherical | |
| | spherical electrodes. | electrodes. | |
| | To turn the RenuSpa iO | To turn the NuBODY | |
| | device on, the on/off | device on, the on/off | |
| | button is pressed. | button is pressed. | |
| | Ascending tonal beeps | Ascending tonal beeps | |
| | indicate the RenuSpa iO | indicate the NuBODY | |
| | device is on. Five LED | device is on. One to | |
| | lights illuminate indicating | three LED lights | |
| | the treatment time | illuminate indicating the | |
| | duration and the unit is | output intensity level and | |
| | ready for use. | the unit is ready for use. | |
| | The four elongated | The four spheres gently | |
| | spheres gently glide over | glide over the skin to | |
| | the skin to deliver low- | deliver low-level | |
| | level electrical impulses | electrical impulses to | |
| | to targeted locations on | targeted locations on the | |
| | the body. | body. | |
| | The RenuSpa iO device | The NuBODY device | |
| | elongated spheres are | spheres are designed for | |
| | designed for optimal | optimal contact with body | |
| | contact with body skin. | skin. The NuBODY | |
| | The RenuSpa iO device | device delivers | |
| | delivers microcurrent as a | microcurrent as a | |
| | constant monophasic | constant monophasic | |
| | square wave comprised | square wave comprised | |
| | of a burst of (10) positive | of a burst of (10) positive | |
| | pulses followed by a | pulses followed by a | |
| | burst of (10) negative | burst of (10) negative | |
| pulses. | | pulses. | |
| | The microcurrent output | The microcurrent output | |
| | continuously alternates | continuously alternates | |
| | between the positive and | between the positive and | |
| | negative elongated | negative spherical | |
| | spherical electrodes. | electrodes and allows the | |
| | The RenuSpa iO device | user to adjust the output | |
| | requires the use of a | for a personalized | |
| | conductive gel. | comfort level. | |
| | To promote proper use | The NuBODY device | |
| | and provide feedback to | requires the use of a | |
| | the user, the RenuSpa iO | conductive gel. | |
| | device provides | | |
| continuous white noise<br>when the device is in<br>proper contact with the<br>skin. | To promote proper use<br>and provide feedback to<br>the user, the NuBODY<br>device beeps to cue the<br>user to relocate the<br>NuBODY device<br>approximately every 5<br>seconds. | | |

# Table 1 – General Comparison Table

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# Table 2 – Basic Unit Comparison

| Basic Unit<br>Comparison Table | Nu Skin RenuSpa iO<br>(New Device) | NuBODY (Predicate) | Remark |
|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------|
| Power Source | Internal rechargeable<br>Lithium-ion battery | Internal rechargeable<br>Lithium-ion battery | Same |
| a. Method of<br>Line Current<br>Isolation | Type BF | Type BF | Same |
| b. Patient<br>Leakage<br>Current | (See 1) and 2) below) | - | - |
| 1) Normal<br>condition | N/A- Battery Operated | N/A- Battery Operated | Same |
| 2) Single Fault<br>Condition | N/A- Battery Operated | N/A- Battery Operated | Same |
| External power<br>adapter | Nu Skin 5-volt USB-A<br>Wireless Charger. | NuFACE 5-volt power<br>adapter | Difference<br>Note 2 |
| Number of<br>Output<br>Channels | 1 | 1 | Same |
| a) Synchronous<br>or Alternating | N/A - 1 Output<br>channel | N/A - 1 Output<br>channel | Same |
| b) Method of<br>Channel<br>Isolation | N/A - 1 Output<br>channel | N/A - 1 Output<br>channel | Same |
| Regulated<br>Current or<br>Regulated<br>Voltage | Both | Both | Same |
| Software/<br>Firmware/<br>Microprocessor<br>Control | Yes | Yes | Same |
| Automatic<br>Overload Trip | Not required due to<br>circuit design | Not required due to<br>circuit design | Same |
| Automatic<br>Non load Trip | Yes | Yes | Same |
| Automatic Shut<br>Off | Yes | Yes | Same |
| Patient<br>Override<br>Control | Yes | Yes | Same |
| Indicator Display | | | |
| a) On-Off status | Yes | Yes | Same |
| b) Low Battery | Yes | Yes | Same |
| c) Voltage/<br>Current Level | Yes | Yes | Same |
| Automatic Shut-Off<br>(minutes) | Yes (5minutes) | Yes (5minutes) | Same |
| Compliance<br>with Voluntary<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>ISO 14971<br>IEC 60601-1-6<br>IEC 62366<br>IEC 60601-1-11 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60529<br>IEC 60601-2-10<br>ISO 14971<br>IEC 60601-1-6<br>IEC 62366 | Difference<br>Note 2 |
| Weight | Approximately 6.7 oz.<br>Without power adapter | Approximately 10-14<br>oz. without power<br>adapter | Difference<br>Note 3 |
| Dimensions of<br>device(inch) [W<br>x L x D] | Approximately 5.1" x<br>2.9" x 2.9" | Approximately 2.75" x<br>6.5" x 6.0" | Difference<br>Note 3 |
| Housing<br>Materials and<br>Construction | Thermoplastic | Thermoplastic | Same |
| Output<br>Specification<br>Comparison Table | Nu Skin RenuSpa iO<br>(New Device) | NuBODY (Predicate) | Remark |
| Waveform (e.g.,<br>Pulsed monophasic, biphasic) | Monophasic<br>waveform that is<br>delivered in a burst of<br>pulses | Monophasic<br>waveform that is<br>delivered in a burst of<br>pulses | Same |
| Shape (e.g.,<br>rectangular, spike,<br>rectified sinusoidal) | Voltage Modulated<br>Square | Voltage Modulated<br>Square | Same |
| Maximum<br>Output Voltage | 22 VDC | 28 VDC | Difference<br>Note 4 |
| Maximum<br>Output Current | 640 μΑ | 900 µA @ 500Ω | Difference<br>Note 4 |
| Maximum Output<br>Current Density | 0.320 mA/cm2 | 0.468 mA/cm2 | Difference<br>Note 4 |
| Output Current<br>when not stimulating | < 1 µA | < 1 µA | Same |
| Output Tolerance | +/- 10% | +/- 10% | Same |
| Pulse Width | 60 ms | 60 ms | Same |
| Frequency (Hz) | Approximately 8.3 Hz | Approximately 8.3 Hz | Same |
| For interferential<br>modes, only<br>a) Beat<br>Frequency<br>(Hz) | No Beat Frequency | No Beat Frequency | Same |
| For multiphasic<br>waveforms, only<br>a) Symmetrical<br>phases | Not Multiphasic | Not Multiphasic | Same |
| b) Phase<br>Duration<br>(include<br>units)<br>c) (state range,<br>if applicable)<br>d) (both phases,<br>if<br>asymmetrical) | Not Multiphasic | Not Multiphasic | Same |
| Net Charge (μC<br>per pulse) | 38.4 µC | 54 µC | Difference<br>Note 4 |
| Burst Mode (i.e.,<br>pulse trains) | | | |
| a) Pulses per<br>burst | 20 | 20 | Same |
| b) Pulses per<br>second | 8.3 | 8.3 | Same |
| c) Burst<br>duration<br>(seconds) | 2.4 s | 2.4 s | Same |
| d) Duty Cycle<br>[Line (b) x<br>line (c)] (on<br>time per<br>burst) | 20.2 s | 20.2 s | Same |
| ON Time (seconds) | 60 msec | 60 msec | Same |
| OFF Time (seconds) | 60 msec | 60 msec | Same |
| Maximum<br>Average Power<br>Density<br>(mW/cm2) | 3.52 | 4.18 | Difference<br>Note 4 |
| Maximum Phase<br>Charge (mC/Burst) | 0.768 | 1.08 | Difference<br>Note 4 |

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Table 3 – Output Specification Comparison Table

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Nonclinical testing was performed to demonstrate that the Nu Skin product met design specifications and is substantially equivalent to the NUBODY Plus predicate device. This performance testing was conducted using a production equivalent of the Nu Skin, and a commercial unit of the predicate. The testing consisted of the evaluation of output waveform characteristics and output energy characteristics.

Additionally, Product Safety and EMC testing of the Nu Skin was conducted in accordance with IEC 60601-1 and IEC 60601-1-2. The Nu Skin device conformed to ANSI/AAMI IEC 60601-1: 2005 / A2:2010 for Electrical and Constructional Safety and to IEC 60601-1-2 for Electromagnetic Compatibility (EMC) and IEC 60601-2-10.

All nonclinical test results for output waveform, output energy, Electrical and Constructional Safety and EMC confirm the Nu Skin device is substantially equivalent to the NUBODY predicate device.

As such, any differences between the new device and the predicate do not raise any new issues related to safety and efficacy.

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# General Comparisons

# Technological Characteristics

The new device is similar but slightly different than the predicate in that:

1. The predicate has smooth spherical electrodes as opposed to smooth elongated spherical electrodes in the new device.

2. The predicate LED lights indicate output intensity modification and are not present in the new device. The new device LED lights indicate treatment time elapsed.

3. The predicate allows the user to change intensity and is not present in the new device.

4. The predicate provides feedback of proper use via beep cues every 5 seconds; the new device provides feedback of proper use via continuously emitting white noise. Therefore, these differences don't raise any new issues related to safety and efficacy.

# Note 1:

The new device and predicate device have many similarities in technological characteristics except for electrodes, materials, and user interface functions. Both have passed the biocompatibility tests. For more stability and better contact, the proposed device uses fixed, elongated spherical electrodes, and provides user interface functions that differ from the predicate device (audible cues and LED lights). The proposed device has passed the IEC 60601-1, 60601-1-2 tests. Therefore, these differences don't raise any new issues related to safety and efficacy.

# Basic Unit Comparisons

# External Power Adapter

The predicate device provides a 5-volt power adapter that plugs in directly into the device via a barrel connection. This power adapter includes a built-in mains wall adapter that is included as part of the power adapter.

The new device provides a 5-volt USB-A power adapter that charges wirelessly. This power adapter does not include a built-in mains wall adapter and relies on a customer provided a certified USB-A mains wall adapter with appropriate electrical ratings. Like the predicate, the new device passes testing as part of AAMI/ANSI IEC 60601-1 for safety and to IEC 60601-1-2 for Electromagnetic Compatibility (EMC). Therefore, these differences don't raise any new issues related to safety and efficacy.

# Compliance with Voluntary Standards

The predicate device does not list the IEC 60601-1-11 standard under voluntary compliance. The predicate also explicitly lists IEC 60529.

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The new device does list the IEC 60601-1-11 standard due to the use of the device in a home health care environment. The new device does not explicitly list IEC 60529 but rather includes the associated standard as a part of AAMI/ANSI IEC 60601-1 testing. Therefore, these differences don't raise any new issues related to safety and efficacy.

#### Note 2:

The tests performed by our proposed device are slightly different from those of the predicate device. IEC 60529 is the standard for device waterproof level testing, and the waterproof level of our device has been evaluated in the AAMI/ANSI IEC 60601-1 test. The predicate device provided a 5-volt plug in adapter while the new device provides a wireless adapter passed testing as part of AAMI/ANSI IEC 60601-1 for safety and to IEC 60601-1-2 for Electromagnetic Compatibility (EMC). Therefore, these differences don't raise any new issues related to safety and efficacy.

# Weight (oz)

The predicate device weighs approximately 10-14 oz. without the power adapter due to older industrial design, internal components, and materials used.

The new device weighs approximately 6.7 oz. without the power adapter due to the newer smaller industrial design, internal components, and materials used to improve device handling. Therefore, these differences don't raise any new issues related to safety and efficacy.

# Dimensions (Inches)

The predicate NuFACE device dimensions measure approximately 2.75" x 6.5" x 6.0" due to older industrial design, internal components, and materials used. The new device dimensions measure approximately 5.1" x 2.9" due to newer smaller industrial design, internal components, and materials used to improve device handling. Therefore, these differences don't raise any new issues related to safety and efficacy.

# Note 3:

The proposed device is different from the predicate device in housing material, weight, dimensions, and appearance. Both have passed the biocompatibility tests, IEC 60601-1, 60601-1-2 tests. Therefore, these differences don't raise any new issues related to safety and efficacy.

# Output Specification Comparison

Maximum Output Voltage (V)

The predicate device has a maximum output voltage of 28 VDC.

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The new device has a maximum output voltage of 22 VDC. This lowering of the maximum voltage output allows for similar efficacy and is optimal for an improved user experience. Therefore, these differences don't raise any new issues related to safety and efficacy.

#### Maximum Output Current (uA)

The predicate device has a maximum output current of 900uA at a measured resistance of 500 Ω. The exact maximum output current, regardless of impedance load, is estimated to be around 920 - 940 uA due to calculations around listed specifications and ratings.

The new device has a maximum output current of 640uA and is a true maximum output current…