(61 days)
Not Found
No
The summary describes a device that delivers electrical impulses (microcurrent) and does not mention any AI or ML capabilities, image processing, or data analysis that would typically indicate the presence of such technology.
No.
The device is intended for "over-the-counter cosmetic use" and "body skin stimulation," which are not considered therapeutic indications.
No
The device is described as a "Skin Toning Device" intended for "body skin stimulation" and "over-the-counter cosmetic use," delivering "low level electrical impulses (microcurrent)." There is no indication that it is used to diagnose any medical condition.
No
The device description explicitly states that the device has "Four (4) spherical electrodes, fixed on the NuBODY device main body, deliver low level electrical impulses (microcurrent)". This indicates the presence of physical hardware components that deliver the intended therapy, making it a hardware device, not software-only.
Based on the provided information, the NuBODY Skin Toning Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "body skin stimulation" and "over-the-counter cosmetic use." This clearly indicates a purpose related to the physical appearance of the body, not the diagnosis of diseases or conditions.
- Device Description: The device delivers "low level electrical impulses (microcurrent) to targeted locations on the body." This is a physical interaction with the body, not an analysis of biological samples.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The NuBODY device does not perform any such analysis.
Therefore, the NuBODY Skin Toning Device falls under the category of a cosmetic or aesthetic device, not an IVD.
N/A
Intended Use / Indications for Use
NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Areas of the body other than the face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter cosmetic use.
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)
Nonclinical testing was performed to demonstrate that the NuBODY product met design specifications and is substantially equivalent to the NuFACE Plus predicate device. This performance testing was conducted using a production equivalent of the NuBODY, 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 NuBODY was conducted in accordance with IEC 60601-1 and IEC 60601-1-2. The NuBODY device conformed to ANSI/AAMI ES60601-1: 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 NuBODY device is substantially equivalent to the NuFACE Plus predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
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: (760) 509-1264 Facsimile: (760) 650-3667 DELLIS@mynuface.com 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.
4
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.
5
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
(NEW DEVICE) | NuFACE Plus Device
(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
(NEW DEVICE) | NUFACE PLUS DEVICE
(PREDICATE) |
| | electrodes. To turn the
NuBODY device on, the
on/off button is pressed.
Ascending tonal beeps
indicate the NuBODY device
is on. One to three LED lights
illuminate indicating the
output intensity level and the
unit is ready for use. The four
spheres gently glide over the
skin to deliver low-level
electrical impulses to
targeted locations on the
body. The NuBODY device
spheres are designed for
optimal contact with body
skin. The NuBODY device
delivers microcurrent as a
constant monophasic
square wave comprised of a
burst of (10) positive pulses
followed by a burst of (10)
negative pulses. The
microcurrent output
continuously alternates
between the positive and
negative spherical
electrodes, and allows the
user to adjust the output for
a personalized comfort level.
The NuBODY device requires
the use of a conductive gel.
To promote proper use and
provide feedback to the
user, the NuBODY device
beeps to cue the user to
relocate the NuBODY device
approximately every 5
seconds. | button is pressed.
Ascending tonal beeps
indicate the device is on.
One to five red LED lights
illuminate indicating the
output intensity level and
the unit is ready for use.
Users then follow the
instructions for use. The
two spheres gently glide
over the skin to deliver
low-level electrical
impulses to targeted
locations on the face. The
NuFACE Plus spheres are
designed for optimal
contact with the face.
The NuFACE Plus device
delivers microcurrent as a
constant monophasic
square wave comprised
of a burst of (10) positive
pulses followed by a burst
of (10) negative pulses.
The microcurrent output
continuously alternates
between the positive and
negative electrode
spheres, and allows the
user to adjust the output
for a personalized comfort
level. The NuFACE Plus
device requires the use of
a conductive gel. To
promote proper use and
provide feedback to the
user, the NuFACE Plus
beeps to cue the user to
relocate the device
approximately every 5
seconds. |
| BASIC UNIT
CHARACTERISTICS | NuBODY
(NEW DEVICE) | NuFACE Plus Device
(PREDICATE) |
| 1. 510(k) Number | K171588 | K103472 |
| 2. Device Name,
Model | NuBODY Skin Toning
Device | NuFACE Plus Facial
Toning Device |
| 3. Manufacturer | Carol Cole Company
(dba NuFACE) | Carol Cole Company
(dba NuFACE) |
| 4. Power Source(s) | Internal rechargeable
Lithium ion battery | Internal rechargeable
Lithium ion battery |
| a. Method of
Line Current
Isolation | Type BF | Type BF |
| b. Patient
Leakage
Current | | |
| 1). Normal
condition | N/A - Battery
operated | N/A - Battery
operated |
| 2). Single
fault
condition | N/A - Battery
operated | N/A - Battery
operated |
| 5. External power
adapter | NuFACE 5-volt power
adapter | NuFACE 7-volt power
adapter |
| 6. Number of
Output
Channels | 1 | 1 |
| a. Synchronous
or Alternating | N/A - 1 Output
channel | N/A - 1 Output
channel |
| b. Method of
Channel
Isolation | N/A - 1 Output
channel | N/A - 1 Output
channel |
| 7. Regulated
Current or
Regulated
Voltage | Both | Both |
| 8. Software/
Firmware/
Microprocessor
Control | Yes | Yes |
| 9. Automatic
Overload Trip | Not required due to
circuit design | Not required due to
circuit design |
| BASIC UNIT
CHARACTERISTICS | NuBODY
(NEW DEVICE) | NUFACE PLUS DEVICE
(PREDICATE) |
| 10. Automatic No-
Load Trip | Yes | Yes |
| 11. Automatic Shut
Off | Yes | Yes |
| 12. Patient
Override
Control | Yes | Yes |
| 13. Indicator
Display | | |
| a. On/Off
Status | Yes | Yes |
| b. Low Battery | Yes | Yes |
| c. Voltage/Curr
ent Level | Yes | Yes |
| 14. Automatic
Shut-Off
(minutes) | Yes (5 minutes) | Yes (20 minutes) |
| 15. Compliance
with Voluntary
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60529
IEC 60601-2-10
ISO 14971
IEC 60601-1-6
IEC 62366 | IEC 60601-1
IEC 60601-1-2 |
| 16. Compliance
with 21 CFR 898 | Yes | Yes |
| 17. Weight | Approximately 10-14
oz. without power
adapter | 9 oz. without
charging base |
| 18. Dimensions of
device(inch) [W
x L x D] | Approximately 2.75" x
6.5" x 6.0" | 2.8" x 5.1" x 1.3" |
| 19. Housing
Materials and
Construction | Thermoplastic | Thermoplastic |
| OUTPUT SPECIFICATIONS | NuBODY
(NEW DEVICE) | NuFACE Plus DEVICE
(PREDICATE) |
| 1. 510(k) Number | K171588 | K103472 |
| 2. Waveform (e.g.,
pulsed
monophasic,
biphasic) | Monophasic
waveform that is
delivered in a burst of
pulses | Monophasic
waveform that is
delivered in a burst
of pulses |
| 3. Shape (e.g.,
rectangular,
spike, rectified
sinusoidal) | Voltage Modulated
Square | Voltage Modulated
Square |
| 4. Maximum
Output Voltage | 28 VDC | 28 VDC |
| 5. Maximum
Output Current | 900 μA @ 500Ω | 400 μA @ 500Ω |
| 6. Maximum
Output Current
Density | 0.468 mA/cm² | 0.419 mA/cm² |
| 7. Output Current
when not
stimulating |