NuBODY Skin Toning Device

K171588 · Carol Cole Company Dba Nuface · NFO · Jul 31, 2017 · Neurology

Device Facts

• Record ID: K171588
• Device Name: NuBODY Skin Toning Device
• Applicant: Carol Cole Company Dba Nuface
• Product Code: NFO · Neurology
• Decision Date: Jul 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

Device Story

The NuBODY Skin Toning Device is a handheld, battery-operated device for over-the-counter cosmetic body skin stimulation. It features four fixed, chrome-plated spherical electrodes that deliver low-level electrical impulses (microcurrent) to targeted body areas. The device requires the application of a conductive gel. Operation involves pressing an on/off button, with ascending tonal beeps indicating activation and LED lights indicating output intensity. The device delivers a continuous alternating monophasic square wave, consisting of a burst of 10 positive pulses followed by a burst of 10 negative pulses. It provides audible cues every 5 seconds to prompt the user to relocate the device. Users can adjust the output intensity for comfort. The device automatically shuts off after 5 minutes. By delivering microcurrent to the skin, the device is intended to provide cosmetic toning benefits.

Clinical Evidence

Bench testing only. Testing included evaluation of output waveform characteristics, output energy characteristics, electrical and constructional safety (ANSI/AAMI ES60601-1), and electromagnetic compatibility (IEC 60601-1-2). Results confirmed the device meets design specifications and is substantially equivalent to the predicate.

Technological Characteristics

Handheld device with injection-molded thermoplastic resin housing. Four chrome-plated spherical electrodes. Powered by internal rechargeable lithium-ion battery. Delivers microcurrent as a continuous alternating monophasic square wave (60 ms pulse width, ~8.3 Hz frequency). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60529, IEC 60601-2-10, IEC 60601-1-6, and IEC 62366. Type BF patient contact.

Indications for Use

Indicated for over-the-counter cosmetic body skin stimulation 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

• NuFACE® Plus (K103472)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 31, 2017

Carol Cole Company dba NuFACE Donald Ellis Regulatory Affairs / Ouality Assurance Manager 1325 Sycamore Ave, Suite A Vista, California 92081

Re: K171588

Trade/Device Name: NuBODY Skin Toning Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: May 31, 2017 Received: May 31, 2017

Dear Donald Ellis:

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 (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. 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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K171588

Device Name NuBODY Skin Toning Device

Indications for Use (Describe)

NuBODY Skin Toning Device 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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Image /page/3/Picture/0 description: The image shows the logo for NuFace. The logo is in gray and features the brand name in a simple, sans-serif font. The "U" in NuFace has a horizontal line above it.

### SECTION 5. 510(K) SUMMARY

DATE PREPARED: July 27, 2017

### 510(K) SUBMITTER/OWNER

Carol Cole Company 1325 Sycamore Ave, Suite A Vista, CA 92081, USA

### CONTACT INFORMATION:

Donald Ellis, Requlatory Affairs/Quality Assurance Phone: [phone] Facsimile: [phone] [e-mail] Email:

### DEVICE NAMES

Device Trade/ Proprietary Name: Device Common or Usual Name: Classification Name:

NuBODY Skin Toning Device NuBODY stimulator, transcutaneous electrical, aesthetic purposes 21 CFR 882.5890 NFO

Requlation Number: Product Code:

### PREDICATE DEVICES

The legally marketed predicate device to which the Carol Cole Company is claiming equivalence for over-the-counter use:

| 510(k) Number: | K103472 |
|----------------|-------------------------------|
| Manufacturer: | Carol Cole Company dba NuFACE |
| Trade Name: | NuFACE® Plus |
| Product Code: | NFO |

### DEVICE DESCRIPTION

NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. Four (4) spherical electrodes, fixed on the NuBODY device main body, deliver low level electrical impulses (microcurrent) to targeted locations on the body.

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# NUFACE

1325 Sycamore Avenue, Suite A, Vista, CA 92081

### INTENDED USE

NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

### Technological Characteristics

The proposed NuBODY device has the same, or similar, technological characteristics as the NuFACE Plus predicate device. The differences do not alter the clinical utility of our proposed NuBODY device relative to the cleared NuFACE Plus predicate device listed below.

- NuBODY device is powered by a rechargeable, nonreplaceable, battery i) which uses a lithium ion chemistry.
- Microcurrent is discharged through four (4) smooth, chrome-plated, ii) spherical electrodes.
- iii) Comparable to the NuFACE Plus predicate device, the NuBODY device generates continuous alternating microcurrent delivered in a burst of positive pulses followed by a burst of negative pulses.

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Image /page/5/Picture/0 description: The image shows the word "NUFACE" in a sans-serif font. The letters are gray and evenly spaced. There is a horizontal line above the "U" in "NUFACE", and a small circle above and to the right of the "E".

# Predicate Comparison

# Table1: General Comparison Table

| DEVICE DESCRIPTIONS | NuBODY<br>(NEW DEVICE) | NuFACE Plus Device<br>(PREDICATE) |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. 510(k) Number | K171588 | K103472 |
| 2. Regulation Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 |
| 3. Regulation Name | Transcutaneous electrical nerve stimulator for pain relief | Transcutaneous electrical nerve stimulator for pain relief |
| 4. Regulatory Class | Class II | Class II |
| 5. Device Classification Name | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| 6. Product Code | NFO | NFO |
| 7. Regulation Medical Specialty | Neurology | Neurology |
| 8. Intended Use | NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. | NuFACE Plus Facial Toning Device is intended for facial stimulation and is indicated for over the counter cosmetic use. |
| 9. Indications for Use | Over-the-Counter Cosmetic Use | Over-the-Counter Cosmetic Use |
| 10. Anatomic Sites | Areas of the body other than the face | Face |
| 11. Technological Characteristics | The NuBODY Skin Toning Device is a body skin toning device. Its outer case is injection molded thermoplastic resin. The output contacts consist of chrome-plated spherical electrodes. The NuBODY device is powered by a rechargeable lithium ion battery. NuBODY device produces microcurrent that is discharged through four fixed, smooth spherical | The NuFACE Plus is a facial toning device. Its outer case is injection molded thermoplastic resin. The output contacts consist of chrome-plated spheres. The device is powered by a rechargeable lithium ion battery and produces a microcurrent that is discharged through two fixed, smooth electrode spheres. To turn the device on the on/off |
| DEVICE DESCRIPTIONS | NuBODY<br>(NEW DEVICE) | NUFACE PLUS DEVICE<br>(PREDICATE) |
| | electrodes. To turn the<br>NuBODY device on, the<br>on/off button is pressed.<br>Ascending tonal beeps<br>indicate the NuBODY device<br>is on. One to three LED lights<br>illuminate indicating the<br>output intensity level and the<br>unit is ready for use. The four<br>spheres gently glide over the<br>skin to deliver low-level<br>electrical impulses to<br>targeted locations on the<br>body. The NuBODY device<br>spheres are designed for<br>optimal contact with body<br>skin. The NuBODY device<br>delivers microcurrent as a<br>constant monophasic<br>square wave comprised of a<br>burst of (10) positive pulses<br>followed by a burst of (10)<br>negative pulses. The<br>microcurrent output<br>continuously alternates<br>between the positive and<br>negative spherical<br>electrodes, and allows the<br>user to adjust the output for<br>a personalized comfort level.<br>The NuBODY device requires<br>the use of a conductive gel.<br>To promote proper use and<br>provide feedback to the<br>user, the NuBODY device<br>beeps to cue the user to<br>relocate the NuBODY device<br>approximately every 5<br>seconds. | button is pressed.<br>Ascending tonal beeps<br>indicate the device is on.<br>One to five red LED lights<br>illuminate indicating the<br>output intensity level and<br>the unit is ready for use.<br>Users then follow the<br>instructions for use. The<br>two spheres gently glide<br>over the skin to deliver<br>low-level electrical<br>impulses to targeted<br>locations on the face. The<br>NuFACE Plus spheres are<br>designed for optimal<br>contact with the face.<br>The NuFACE Plus device<br>delivers microcurrent as a<br>constant monophasic<br>square wave comprised<br>of a burst of (10) positive<br>pulses followed by a burst<br>of (10) negative pulses.<br>The microcurrent output<br>continuously alternates<br>between the positive and<br>negative electrode<br>spheres, and allows the<br>user to adjust the output<br>for a personalized comfort<br>level. The NuFACE Plus<br>device requires the use of<br>a conductive gel. To<br>promote proper use and<br>provide feedback to the<br>user, the NuFACE Plus<br>beeps to cue the user to<br>relocate the device<br>approximately every 5<br>seconds. |
| BASIC UNIT<br>CHARACTERISTICS | NuBODY<br>(NEW DEVICE) | NuFACE Plus Device<br>(PREDICATE) |
| 1. 510(k) Number | K171588 | K103472 |
| 2. Device Name,<br>Model | NuBODY Skin Toning<br>Device | NuFACE Plus Facial<br>Toning Device |
| 3. Manufacturer | Carol Cole Company<br>(dba NuFACE) | Carol Cole Company<br>(dba NuFACE) |
| 4. Power Source(s) | Internal rechargeable<br>Lithium ion battery | Internal rechargeable<br>Lithium ion battery |
| a. Method of<br>Line Current<br>Isolation | Type BF | Type BF |
| b. Patient<br>Leakage<br>Current | | |
| 1). Normal<br>condition | N/A - Battery<br>operated | N/A - Battery<br>operated |
| 2). Single<br>fault<br>condition | N/A - Battery<br>operated | N/A - Battery<br>operated |
| 5. External power<br>adapter | NuFACE 5-volt power<br>adapter | NuFACE 7-volt power<br>adapter |
| 6. Number of<br>Output<br>Channels | 1 | 1 |
| a. Synchronous<br>or Alternating | N/A - 1 Output<br>channel | N/A - 1 Output<br>channel |
| b. Method of<br>Channel<br>Isolation | N/A - 1 Output<br>channel | N/A - 1 Output<br>channel |
| 7. Regulated<br>Current or<br>Regulated<br>Voltage | Both | Both |
| 8. Software/<br>Firmware/<br>Microprocessor<br>Control | Yes | Yes |
| 9. Automatic<br>Overload Trip | Not required due to<br>circuit design | Not required due to<br>circuit design |
| BASIC UNIT<br>CHARACTERISTICS | NuBODY<br>(NEW DEVICE)…