The NuFACE® Mini Device is a non-invasive at home, over-the-counter facial toning device. The dual spheres of the NuFACE® Mini Device are designed for optimal contact with the face and are identical in size to the predicate device. The NuFACE® Mini Device is extremely responsive as it delivers soft wave micro-current in the millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles.

The NuFACE® Mini device measures 2.5" W x 4.2" L x 1.2" D. Its outer case is injection molded of thermoplastic resin. The device comes with an external Power Supply to charge the internal batteries of the device when not in use. The external Power Supply provides DC power from a pre-approved wall adapter. All charging circuitry is contained within the device itself. The microcurrent output is disabled when the device is connected to the external Power Supply.

An ascending sequence of beeps informs the customer the NuFACE® Mini is ready for use. When the user turns the device OFF, a descending tone is emitted. A single control button is used to turn the device on and off and to change the device's output intensity. A long press of the control button toggles the device between on and off.

To promote proper use, a single audio beep informs the user to relocate the device to treat a new location on the skin. The user can also adjust the output intensity by briefly pressing the control button to step between multiple micro-current output level selections. When the device is set to the maximum output and the control button is pressed, the device sequences to the minimum output.

AI/ML Overview

The NuFACE® Mini Device's acceptance criteria and the study proving it meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NuFACE® Mini Device are based on demonstrating substantial equivalence to its predicate device, the NuFACE® Trinity device (cleared as NuFACE® Plus, K103472). This means that the NuFACE® Mini Device must have identical or nearly identical technological characteristics and performance specifications for its intended use.

Here's a comparison table summarizing the core electrical output specifications which form the primary acceptance criteria for demonstrating functional equivalence:

Acceptance Criteria (Predicate Device Specification)	NuFACE® Mini Device Performance	Comparison Result
Waveform Type: Pulsed Monophasic	Pulsed Monophasic	Identical
Waveform Shape: Modulated Square	Modulated Square	Identical
Maximum Output Voltage:
- 137 mV @ 500 Ω	222 mV @ 500 Ω	Different (Higher) - Note: The document states "identical to the predicate" but the values differ.
- 769 mV @ 2 kΩ	781 mV @ 2 kΩ	Different (Higher) - Note: The document states "identical to the predicate" but the values differ.
- 3.82 V @ 10 kΩ	3.90 V @ 10 kΩ	Different (Higher) - Note: The document states "identical to the predicate" but the values differ.
Maximum Output Current:
- 274 μA @ 500 Ω	396 μA @ 500 Ω	Different (Higher) - Note: The document states "identical to the predicate" but the values differ.
- 387 μA @ 2 kΩ	395 μA @ 2 kΩ	Different (Higher) - Note: The document states "identical to the predicate" but the values differ.
- 383μA @ 10 kΩ	391 μA @ 10 kΩ	Different (Higher) - Note: The document states "identical to the predicate" but the values differ.
Output Tolerance: +/- 2%	+/- 2%	Identical
Pulse Width: 119 ms (Total)	ON phase: 60.4 ms, OFF phase: 60.4 ms, Total Pulse Width: 120.8 ms	Different (Slightly longer total pulse width) - Note: The document states "identical to the predicate" but the values differ.
Frequency: 8.40 Hz	8.28 Hz	Different (Slightly lower) - Note: The document states "identical to the predicate" but the values differ.
Maximum Phase Charge: 23.6 µC @ 500 Ω	23.7 µC @ 500 Ω	Different (Slightly higher) - Note: The document states "identical to the predicate" but the values differ.
Maximum Current Density: 0.512 mA/cm² @ 500 Ω	0.514 mA/cm² @ 500 Ω	Different (Slightly higher) - Note: The document states "identical to the predicate" but the values differ.
Maximum Power Density: 1991 μW/cm² @ 10k Ω	1981 μW/cm² @ 10k Ω	Different (Slightly lower) - Note: The document states "identical to the predicate" but the values differ.
Burst Mode:
- Pulses per burst: 20	20	Identical
- Pulses per second: 8.40	8.28	Different (Slightly lower) - Note: The document states "identical to the predicate" but the values differ.
- Burst duration (s): 2.40	2.42	Different (Slightly longer) - Note: The document states "identical to the predicate" but the values differ.
- Duty Cycle (on time per burst): 20.2	20	Different (Slightly lower) - Note: The document states "identical to the predicate" but the values differ.
ON Time: Constant	Constant	Identical

Note on "Identical" Claims vs. Reported Values:
The summary prominently states that numerous output characteristics are "identical to the predicate." However, the detailed "Output Specifications" table provided later in the document (Section 3) shows minor numerical differences for Maximum Output Voltage, Maximum Output Current, Pulse Width, Frequency, Maximum Phase Charge, Maximum Current Density, Maximum Power Density, Pulses per second, Burst duration, and Duty Cycle. Despite these small numerical variations in the detailed table, the overall conclusion of "substantial equivalence" implies that these differences were deemed insignificant for the device's safety and effectiveness relative to the predicate by the FDA. The submission likely argues that these slight numerical differences fall within acceptable engineering tolerances or do not alter the fundamental mechanism of action or safety profile.

Additional acceptance criteria based on compliance standards are:

Compliance with FDA's performance Standards set forth in 21 CFR §898.
Compliance with IEC 60601-1-2:2010 for radiated and power line conducted emissions.
Compliance with IEC 60601-1:2005 (3rd edition) for Electrical Safety.

The reported performance confirms compliance with these standards (Yes for 21 CFR 898, IEC 60601-1, IEC 60601-1-2).

2. Sample Size Used for the Test Set and Data Provenance

The study to prove the device meets acceptance criteria was based on non-clinical performance assessment. This type of assessment typically involves laboratory testing of the device's electrical and physical characteristics rather than testing on human subjects.

No specific "test set" in the sense of patient data is mentioned.
The provenance is laboratory testing of the device itself. Given the 510(k) submission is for a US market device, the testing would likely be performed in a controlled laboratory environment to meet US regulatory requirements.
This was a non-clinical evaluation, not a clinical study with a test set of human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the study was a non-clinical performance assessment focusing on device specifications and compliance with standards, not on clinical outcomes requiring expert consensus or ground truth from patient data.
The "ground truth" here is the established specifications and safety profile of the predicate device and relevant industry standards.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set of patient cases requiring adjudication. The assessment was based on direct measurement and comparison of device specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission relies on demonstrating substantial equivalence through comparison of technical specifications and safety standards, not through a clinical evaluation involving human readers or assessment of improved human performance with AI assistance. This device is an over-the-counter cosmetic device, not a diagnostic or therapeutic AI-assisted medical device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This is a standalone electrical stimulation device, not an AI algorithm. The device performance was assessed in a standalone capacity (i.e., its intrinsic electrical outputs) without any human-in-the-loop performance being a specific test metric.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance assessment was based on:

Predicate Device Specifications: The established electrical output and technological characteristics of the NuFACE® Trinity device (NuFACE® Plus), which was previously cleared.
Industry and Regulatory Standards: Compliance with relevant electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and FDA performance standards (21 CFR §898).

8. The Sample Size for the Training Set

Not applicable. This device is an electrical stimulation device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There was no training set for this device.

Summary

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510(k) Summary NuFACE® Mini Device

CONTACT INFORMATION

Rand Daoud. Compliance Specialist Carol Cole Company 1325 Sycamore Ave, Suite A Vista, California 92081

Phone: (760) 734-4545 x126 Facsimile: (760) 650-3667 Email: rdaoud@mynuface.com

DEVICE NAME

Trade Name: NuFACE® Mini Device Common Name: Facial Toning Device Classification Name: Transcutaneous Electrical Nerve Stimulator (21 CFR 882.5890) Product Code: NFO

PREDICATE DEVICE

The Carol Cole Company is claiming substantial equivalence with its own device, the NuFACE® Trinity device, cleared as the NuFACE® Plus under 510(k) K103472. This Abbreviated 510(k) submission is a new design based on the manufacturer's cleared device. The electrical output of the NuFACE® Mini is identical to the previously cleared NuFACE® Trinity Facial Toning Device. Both devices are for transcutaneous electrical nerve stimulation for cosmetic use.

INDICATIONS FOR USE/INTENDED USE

The NuFACE® Mini Device is intended for facial stimulation and is indicated for overthe-counter cosmetic use. (21 CFR 801 Subpart C).

The anatomical site for application of the NuFACE® Mini Device is the face.

TECHNOLOGICAL CHARACTERISTICS

An ascending sequence of beeps informs the customer the NuFACE® Mini is ready for use. When the user turns the device OFF, a descending tone is emitted. A

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single control button is used to turn the device on and off and to change the device's output intensity. A long press of the control button toggles the device between on and off.

COMPLIANCE DATA

The NuFACE® Mini Device is in conformance to the FDA's performance Standards set forth in 21 CFR §898. Additionally, there are no electrode lead wires or patient cables with this device.

The NuFACE® Mini Device will be tested for compliance with IEC 60601-1-2:2010 for radiated and power line conducted emissions and IEC 60601-1:2005 (3rd edition) for Electrical Safety.

SUBSTANTIAL EQUIVALENCE

The NuFACE® Mini device has the same intended use and indications for use as the predicate device. The device also has nearly identical technological characteristics. During design and development, a Risk Analysis of the device was used to identify potential Hazards that could occur in use of the device, or in the event of Failure Modes of device components. The Risk Analysis was used to identify risk reduction measures which have been incorporated in the device design and labeling.

The determination of substantial equivalence for the NuFACE® Mini is based on an assessment of non-clinical performance. This assessment included a comparison of the output of the NuFACE® Mini to that of the predicate. The output performance testing included:

1. Waveform Type
1. Waveform Shape
1. Maximum Output Voltage
1. Maximum Output Current
1. Output Tolerance
1. Pulse Width

1. Output Frequency
1. Maximum Phase Charge
1. Maximum Current Density
1. Maximum Power Density
1. Burst Mode (i.e., pulse trains)
- a. Pulses per burst
- b. Pulses per second
- Burst duration C.
- d. Duty Cycle
1. ON Time

The results are provided in Section 3 (Output Specifications) below. As shown in the Substantial Equivalence Comparison Table:

1. Waveform type is identical to the predicate

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Waveform Shape is identical to the predicate 2.

Maximum Output Voltage is identical to the predicate
Maximum Output Current is identical to the predicate

1. Output Tolerance is identical to the predicate
1. Pulse Width is identical to the predicate
1. Output Frequency is identical to the predicate
1. Maximum Phase Charge is identical to the predicate
1. Maximum Current Density is identical to the predicate
1. Maximum Power Density is identical to the predicate
1. Burst Mode (i.e., pulse trains)
- a. Pulses per burst is identical to the predicate
- Pulses per second is identical to the predicate ﻓ
- Burst duration is identical to the predicate C.
- ರ. Duty Cycle is identical to the predicate

ON Time is identical to the predicate

The main body of the NuFACE® Mini Device is smaller in size than the predicate; however the functionality remains the same. The NuFACE® Mini does not use a charging cradle, but instead is charged from DC power supplied by an external power supply. The interchangeable head feature of the predicate NuFACE® Trinity device has also been eliminated on the NuFACE® Mini Device. The NuFACE® Mini Device will only function as a microcurrent emitting device.

The results support a determination of substantial equivalence in that the NuFACE® Mini provides the same functionality and microcurrent output as the predicate.

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Section 1: Device Descriptions

Section 1: DeviceDescriptions	NuFACE® MiniNew Device	NuFACE® Trinity(Cleared as the NuFACE® Plus)Predicate Device
1. 510(k) Number	K133823	K103472
2. RegulationNumber	21 C.F.R. § 882.5890	21 C.F.R. § 882.5890
3. Regulation Name	Transcutaneous Electrical Nerve Stimulator	Transcutaneous Electrical Nerve Stimulator
4. Regulatory Class	Class II	Class II
5. Product Code	NFO	NFO
6. Intended Use	Stimulate the face; skin toning	Stimulate the face; skin toning
7. Indications forUse	Over-the-Counter Cosmetic Use	Over-the-Counter Cosmetic Use
8. TechnologicalCharacteristics	The NuFACE® Mini is a facial toning device. Thechrome plated dual electrode spheres of theNuFACE® Mini are designed to gently glide overthe skin to deliver low-level electrical impulses tostrategic locations on the face. The NuFACE®Mini electrodes are designed for optimal contactwith the face.The NuFACE® Mini microcurrent continuallyalternates between the positive and negativeelectrodes, and allows the user to adjust settingsfor a personalized comfort level.The outer case of the NuFACE® Mini is injectionmolded of thermoplastic resin. The device comeswith an external Power Supply to charge theinternal batteries of the device, when the device isnot in use. The external Power Supply is a pre-approved wall adapter. All charging circuitry iscontained within the device itself.To turn the device on, the control button ispressed. An ascending sequence of beeps and oneto five LED lights illuminate indicating the unit isready for use. Users then follow the instructionsfor use. The NuFACE® Mini Device requires theuse of a conductive gel or medium duringtreatment. The user can also adjust the outputlevel by briefly pressing the control button to shiftbetween multiple microcurrent output levels.When the device is set to the maximum output andthe control button is pressed, the device sequencesto the minimum output. A long press of thisbutton toggles the device on and off.To promote proper use and feedback to the user,the NuFACE® Mini beeps to cue the user torelocate the device after approximately 5 secondsof treatment. When the user turns off the device.a descending tone is emitted.	The NuFACE® Plus is a facial toning device.Its outer case is injection moldedthermoplastic resin. The output contacts(probes) consist of chrome-plated spheres.The device, powered by four rechargeable AAnickel-metal hydride batteries, produces amicro-current that is discharged through thetwo fixed, smooth spherical probes. To turnthe device on, the on/off button is pressed. Anascending tone sounds, indicating the deviceon. One to five red LED lights illuminateindicating the unit is ready for use. Users thenfollow the instructions for use. The twoprobes gently glide over the skin to deliverlow-level electrical impulses to strategiclocations on the face. The NuFACE® Plusprobes are designed for optimal contact withthe face. The NuFACE® Plus micro-currentcontinually alternates between the positive andnegative probes, and allows the user to adjustsettings for a personalized comfort level. TheNuFACE® Plus device requires the use of aconductive solution or gel. To promote properuse and feedback to the user, the NuFACE®Plus beeps to cue the user to relocate thedevice approximately every 5 seconds. Thebeep also informs the user that the two spheresare making contact with the skin surface. Analert tone sounds to indicate that both probesare not touching the skin during treatment.
Section 2: Basic UnitCharacteristics	NuFACE® Mini DeviceNew Device	NuFACE® Trinity(Cleared as the NuFACE® Plus)- Predicate Device
1. 510(k) Number	K133823	K103472
2. Device Name, Model	NuFACE® Mini Device	NuFACE® Trinity
3. Manufacturer	Carol Cole Company (CCC)	Carol Cole Company (CCC)
4. Power Source(s)
a. Method of Line CurrentIsolation	2 rechargeable AA NiMHbatteries	4 rechargeable AA NiMH batteries
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. Number of Output Modules	1	1
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 orRegulated Voltage?	Both	Both
8. Software/Firmware/Microprocessor Control?	Yes	Yes
9. Automatic Overload Trip?	Not required due to circuitdesign	Not required due to circuit design
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/Current Level?	Yes	Yes
14. Timer Range (minutes)	Yes (21 minutes)	Yes (21 minutes)
15. Compliance with VoluntaryStandards?	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2
16. Compliance with 21 CFR898?	Yes	Yes
17. Weight	6 oz	9 oz without charging base
18. Dimensions of device(inch)[W x L x D]	2.5" W x 4.2" L x 1.2" D	3" W x 5.2" L x 1.25" D
19: Dimensions of charging Unit(inch) [W x L x D]	None	3.25" W x 4.0" L x 3.25" D
20. Housing Materials andConstruction	Thermo Plastic	Thermo Plastic
Section 3: Output Specifications	NuFACE® Mini Device:New Device.	NuFACE® Trinity(Cleared as the NuFACE® Plus)Predicate Device
Waveform (e.g., pulsed monophasic, biphasic)	Pulsed Monophasic	Pulsed Monophasic
Shape (e.g., rectangular, spike, rectified sinusoidal)	Modulated Square	Modulated Square
Maximum Output Voltage (specify units)	222 mV @ 500 Ω781 mV @ 2 kΩ3.90 V @ 10 kΩ	137 mV @ 500 Ω769 mV @ 2 kΩ3.82 V @ 10 kΩ
Maximum Output Current (specify units)	396 μA @ 500 Ω395 μA @ 2 kΩ391 μA @ 10 kΩ	274 μA @ 500 Ω387 μA @ 2 kΩ383μA @ 10 kΩ
Output Current When On, But Not Stimulating(Charging is the only case where this occurs)	1.53 μA @ 10 kΩ	27.8 μA @ 10 kΩ
Output Tolerance	+/- 2%	+/- 2%
Pulse Width (specify units)	ON phase: 60.4 msOFF phase: 60.4 msTotal Pulse Width: 120.8 ms	119 ms
Frequency (Hz)	8.28 Hz	8.40 Hz
For interferential modes only
Beat Frequency (Hz)	No Beat Frequency	No Beat Frequency
For multiphasic waveforms only
Symmetrical phases?	Not Multiphasic	Not Multiphasic
Phase Duration (include units)(state range, if applicable)(both phases, if asymmetrical).	Not Multiphasic	Not Determined
Net Charge (µC per pulse)	1.43 µC @ 500 Ω	1.40 µC @ 500 Ω
Maximum Phase Charge (µC)	23.7 µC @ 500 Ω	23.6 µC @ 500 Ω
Maximum Current Density (mA/cm²)	0.514 mA/cm² @ 500 Ω	0.512 mA/cm² @ 500 Ω
Maximum Power Density (μW/cm²)(using smallest electrode conductive surface area)	1981 μW/cm² @ 10k Ω	1991 μW/cm² @ 10k Ω
Patient Leakage Current During Charging WithNormal Mains Polarity	0.5 μA RMS	0.4 μA RMS
Patient Leakage Current During Charging WithReversed Mains Polarity	0.5 μA RMS	0.6 μA RMS
Burst Mode (i.e., pulse trains)
a. Pulses per burst	20	20
b. Pulses per second	8.28	8.40
c. Burst duration (seconds)	2.42	2.40
d. Duty Cycle [Line (b) x Line (c)](on time per burst)	20	20.2
ON Time (seconds)	Constant	Constant
OFF Time (seconds)	None	None

NuFACE® Mini and NuFACE® Trinity Device Comparison Table

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Section 2: Basic Unit Characteristics

NuFACE® Mini and NuFACE® Trinity Device Substantial Equivalence Comparison Table

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Section 3: Output Specifications NuFACE® Mini and NuFACE® Trinity Device Substantial Equivalence Comparison Table

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble bird wings or flowing lines, creating a sense of movement and representing the department's mission related to health and well-being.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 17, 2014

Carol Cole Company Rand Daoud Compliance Specialist 1325 Sycamore Ave, Suite A Vista. California 92081

Rc: K133823

Trade/Device Name: NuFACE® Mini Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: March 18, 2014 Received: March 19, 2014

Dear Ms. Daoud:

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 10 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 cither class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be Tour 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Rand Daoud

CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 yours,

Felipe Aguel -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133823

Device Name

NuFACE® Mini Device

Indications for Use (Describe)

The NuFACE® Mini Facial Toning device is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21 CFR 807 Subpart C).

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

[] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Date: 2014.04.17 Aqui 18:46:47 -04'00'

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Regulation Number and Section

§ 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).