(139 days)
No
The summary describes a microcurrent device for cosmetic use with standard electrical and mechanical components, and there is no mention of AI or ML in the device description, performance studies, or key metrics.
No.
The intended use explicitly states it is for "body skin stimulation and is indicated for over-the-counter cosmetic use," not therapeutic use.
No.
The device is intended for body skin stimulation for aesthetic purposes, not for diagnosing conditions or diseases.
No
The device description clearly outlines a physical, hand-held, portable, rechargeable microcurrent device with hardware components like a battery, charging stand, and LED lights. It is not solely software.
Based on the provided information, the Nu Skin RenuSpa iO is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "for body skin stimulation and is indicated for over-the-counter cosmetic use." IVD devices are intended for the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a hand-held microcurrent device used for aesthetic purposes on the skin. This aligns with a cosmetic or therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples or providing diagnostic information.
Therefore, the Nu Skin RenuSpa iO falls under the category of a cosmetic or aesthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Nu Skin RenuSpa iO is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
Product codes
NFO
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 USB-enabled 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The following design verification tests were performed on the subject device:
- Dimension verification: Confirms the units meet all dimensional specifications - Acceptance criteria met.
- Visual Inspection: Confirms the product meets all visual specifications - Acceptance criteria met.
- Design Verification: Confirms functionality of units using a clinically relevant bench top model - Acceptance criteria met.
- Software (SW) V&V: Confirms the units meet all SW specifications - Acceptance criteria met.
- Electrical Testing: Confirms electrical functionality of units using a clinically relevant bench top model - Acceptance criteria met.
- Biocompatibility: Confirms the units meet all biocompatibility requirements for this type of device - Acceptance criteria met.
- Cleaning Method Validation: Confirms the units meet all cleaning method expectations for this device - Acceptance criteria met.
- Packaging Distribution Simulation and accelerated aging Testing: Confirms the units meet all packaging distribution simulation and aging requirements - Acceptance criteria met.
Results of tests and assessments did not raise new safety or efficacy questions.
Clinical Testing: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NuBODY Skin Toning Device K171588
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
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 | |
| Correspondent | Jack Slovick |
| Regulatory Consultant | |
| Telephone: 763-639-0238 | |
| Email: jlslovick@gmail.com | |
| 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.
5
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
6
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
Comparison Table | Nu Skin RenuSpa iO
(New Device) | NuBODY (Predicate) | Remark |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510k # | K232001 | K171588 | N/A |
| Indication | Nu Skin RenuSpa iO is
intended for body skin
stimulation and is
indicated for over-the-
counter cosmetic use. | NuBODY Skin Toning
Device is intended for
body skin stimulation and
is indicated for over-the-
counter cosmetic use. | Same |
| Anatomic Sites | Areas of the body other
than
the face | Areas of the body other
than
the face | Same |
| Technological
Characteristics | The Nu Skin RenuSpa iO
Device is a body skin
toning device. Its outer
case is injection molded
thermoplastic resin. The
output contacts consist of
chrome-plated elongated
spherical electrodes. The
RenuSpa iO device is
powered by a
rechargeable lithium-ion
battery. RenuSpa iO
device produces
microcurrent that is
discharged through four | 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, | Difference
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
when the device is in
proper contact with the
skin. | 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. | | |
Table 1 – General Comparison Table
8
9
Table 2 – Basic Unit Comparison
| Basic Unit
Comparison Table | Nu Skin RenuSpa iO
(New Device) | NuBODY (Predicate) | Remark |
|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------|
| Power Source | Internal rechargeable
Lithium-ion battery | Internal rechargeable
Lithium-ion battery | Same |
| a. Method of
Line Current
Isolation | Type BF | Type BF | Same |
| b. Patient
Leakage
Current | (See 1) and 2) below) | - | - |
| 1) Normal
condition | N/A- Battery Operated | N/A- Battery Operated | Same |
| 2) Single Fault
Condition | N/A- Battery Operated | N/A- Battery Operated | Same |
| External power
adapter | Nu Skin 5-volt USB-A
Wireless Charger. | NuFACE 5-volt power
adapter | Difference
Note 2 |
| Number of
Output
Channels | 1 | 1 | Same |
| a) Synchronous
or Alternating | N/A - 1 Output
channel | N/A - 1 Output
channel | Same |
| b) Method of
Channel
Isolation | N/A - 1 Output
channel | N/A - 1 Output
channel | Same |
| Regulated
Current or
Regulated
Voltage | Both | Both | Same |
| Software/
Firmware/
Microprocessor
Control | Yes | Yes | Same |
| Automatic
Overload Trip | Not required due to
circuit design | Not required due to
circuit design | Same |
| Automatic
Non load Trip | Yes | Yes | Same |
| Automatic Shut
Off | Yes | Yes | Same |
| Patient
Override
Control | Yes | Yes | Same |
| Indicator Display | | | |
| a) On-Off status | Yes | Yes | Same |
| b) Low Battery | Yes | Yes | Same |
| c) Voltage/
Current Level | Yes | Yes | Same |
| Automatic Shut-Off
(minutes) | Yes (5minutes) | Yes (5minutes) | Same |
| Compliance
with Voluntary
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10
ISO 14971
IEC 60601-1-6
IEC 62366
IEC 60601-1-11 | IEC 60601-1
IEC 60601-1-2
IEC 60529
IEC 60601-2-10
ISO 14971
IEC 60601-1-6
IEC 62366 | Difference
Note 2 |
| Weight | Approximately 6.7 oz.
Without power adapter | Approximately 10-14
oz. without power
adapter | Difference
Note 3 |
| Dimensions of
device(inch) [W
x L x D] | Approximately 5.1" x
2.9" x 2.9" | Approximately 2.75" x
6.5" x 6.0" | Difference
Note 3 |
| Housing
Materials and
Construction | Thermoplastic | Thermoplastic | Same |
| Output
Specification
Comparison Table | Nu Skin RenuSpa iO
(New Device) | NuBODY (Predicate) | Remark |
| 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 | Same |
| Shape (e.g.,
rectangular, spike,
rectified sinusoidal) | Voltage Modulated
Square | Voltage Modulated
Square | Same |
| Maximum
Output Voltage | 22 VDC | 28 VDC | Difference
Note 4 |
| Maximum
Output Current | 640 μΑ | 900 µA @ 500Ω | Difference
Note 4 |
| Maximum Output
Current Density | 0.320 mA/cm2 | 0.468 mA/cm2 | Difference
Note 4 |
| Output Current
when not stimulating |