The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (21 CFR 801 Subpart C).
The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21 CFR 807 Subpart C).

Device Description

The Trinity ELE is a non-invasive at home, over-the-counter facial stimulation device. The dual spheres of the Trinity ELE are designed for optimal contact with smaller surface areas of the face. The Trinity ELE 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 Trinity ELE continually alternates between the positive and negative probes, and allows the user to adjust settings from approximately 53 to 192 microamps for a personalized comfort level.
The Trinity ELE measures 2.8" W x 6.2" L x 1.3" D. Its outer case is injection molded of thermoplastic resin. The device comes with a Charging Cradle, which measures 3.1" W x 4.0" L x 3.3" D, to charge the internal batteries of the main body when not in use. The Charging Cradle is powered by DC power from a pre-approved wall adapter Power Supply provided with the device. All charging circuitry is contained within the main body unit itself.
An ascending sequence of beeps informs the customer the Trinity ELE is ready for use. When the user turns off the device, a descending tone is emitted.
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 output by pressing the + or - intensity buttons to increase or decrease the micro-current output.

AI/ML Overview

The provided text is a 510(k) summary for the Trinity ELE Device, which is a facial stimulation device. The document primarily focuses on establishing substantial equivalence to a predicate device (NuFACE® Trinity) through a comparison of technological characteristics and output specifications. It does not describe a clinical study or performance data against specific acceptance criteria for efficacy in the same way a diagnostic or therapeutic device might.

Instead, the "acceptance criteria" here are based on demonstrating that the new device (Trinity ELE) is substantially equivalent to a previously cleared device (NuFACE® Trinity), meaning it is as safe and effective. The study that proves this is a non-clinical performance assessment, specifically a direct comparison of the electrical output characteristics of the new device to the predicate device.

Here's a breakdown of the requested information based on the provided text:

1- A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission based on technical characteristics, the "acceptance criteria" can be interpreted as the characteristics of the predicate device. The "reported device performance" is how the Trinity ELE compares to those.

Acceptance Criteria (Predicate Device K103472: NuFACE® Trinity)	Reported Device Performance (Trinity ELE K131251)	Assessment
Waveform type: Pulsed Biphasic	Pulsed Biphasic	Identical to predicate
Waveform Shape: Modulated Square	Modulated Square	Identical to predicate
Max Output Voltage (e.g., 137 mV @ 500 Ω)	Lower (e.g., 96 mV @ 500 Ω)	Less than predicate, but justified by maintaining identical current density with smaller electrodes.
Max Output Current (e.g., 274 μA @ 500 Ω)	Lower (e.g., 193 μA @ 500 Ω)	Less than predicate, but justified by maintaining identical current density with smaller electrodes.
Output Tolerance: +/- 2%	+/- 5%	Note: The document states "Output Tolerance is identical to the predicate" in the narrative but shows different values in the table (5% vs 2%). This discrepancy needs clarification. However, the narrative claims identicality.
Pulse Width: 60 ms	60 ms	Identical to predicate
Frequency: 8.33 Hz	8.33 Hz	Identical to predicate
Max Phase Charge (e.g., 23.9 µC @ 500 Ω)	Lower (e.g., 11.5 µC @ 500 Ω)	Less than predicate, but justified by maintaining identical current density with smaller electrodes.
Max Current Density (e.g., 0.518 mA/cm² @ 500 Ω)	0.739 mA/cm² @ 500 Ω	Note: The narrative states "Max Current Density is identical to the predicate" multiple times, but the table shows a higher value for the Trinity ELE. This discrepancy needs clarification. However, the narrative claims identicality.
Max Power Density (e.g., 1423 µW/cm² @ 500 Ω)	Lower (e.g., 1420 µW/cm² @ 500 Ω)	Less than predicate, but justified by maintaining identical current density with smaller electrodes.
Burst Mode (Pulses per burst): 20	20	Identical to predicate
Burst Mode (Pulses per second): 8.3	8.3	Identical to predicate
Burst Mode (Burst duration): 2.4	2.4	Identical to predicate
Burst Mode (Duty Cycle): 20	20	Identical to predicate
ON Time: Constant	Constant	Identical to predicate
OFF Time: None	None	Identical to predicate

Summary of Device Performance against "Acceptance Criteria": The Trinity ELE device was found to have identical waveform type, waveform shape, pulse width, frequency, burst mode characteristics, ON/OFF times, and (according to the narrative) output tolerance, maximum current density, maximum output voltage, maximum output current, maximum phase charge, and maximum power density after accounting for the smaller electrode size to achieve the same current density. The output voltage, current, phase charge, and power density are listed as lower than the predicate, which the applicant justifies as a necessary consequence of smaller electrodes to maintain identical current density, which is the key metric for tissue interaction.

2- Sample sized used for the test set and the data provenance

Sample Size for Test Set: Not applicable. This was a non-clinical performance assessment comparing device specifications, not a study involving human subjects or real-world data to generate a test set.
Data Provenance: The data is technical specification comparison between the Trinity ELE (new device) and the NuFACE® Trinity (predicate device), presumably obtained through laboratory testing of both devices. There is no mention of country of origin for data or whether it's retrospective/prospective in the context of clinical data, as this is hardware specification testing.

3- Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Ground truth, in this context, would be the measured electrical output specifications of the predicate device, which are inherent to the device's design and operation, not derived from expert consensus on observations.
Qualifications of Experts: Not applicable.

4- Adjudication method for the test set

Adjudication Method: Not applicable. This was a comparison of device specifications, not a clinical study requiring adjudication of outcomes or diagnoses.

5- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, entirely not applicable. This is a submission for a Transcutaneous Electrical Nerve Stimulator, not an AI-assisted diagnostic or imaging device.

6- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical stimulating device, not a software algorithm. The comparison was of the device's inherent electrical output.

7- The type of ground truth used

Type of Ground Truth: The "ground truth" for this substantial equivalence claim is the measured electrical output specifications and physical design characteristics of the legally marketed predicate device (NuFACE® Trinity). The new device's specifications are compared directly against these established characteristics to demonstrate equivalence.

8- The sample size for the training set

Sample Size for Training Set: Not applicable. This device does not involve machine learning or a training set in the conventional sense.

9- How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable, as there is no training set described.

Summary

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K13125/

ОСТ 0 1 2013

510(k) Summarv Trinity ELE Device

Updated: October 1st. 2013

CONTACT INFORMATION

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

Phone: (760) 734-4545 x126 Facsimile: (760) 734-4565 Email: rdaoud@mynuface.com

DEVICE NAME

Trade Name: Trinity ELE Common Name: Facial Stimulation 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. Both devices are for transcutaneous electrical nerve stimulation for cosmetic use.

INDICATIONS FOR USE/INTENDED USE

The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (21 CFR 801 Subpart C).

The anatomical site for application of the Trinity ELE is the face.

TECHNOLOGICAL CHARACTERISTICS

The Trinity ELE measures 2.8" W x 6.2" L x 1.3" D. Its outer case is injection molded of thermoplastic resin. The device comes with a Charging Cradle, which measures 3.1" W x 4.0" L x 3.3" D, to charge the internal batteries of the main body when not in use. The Charging Cradle is powered by DC power from a pre-approved wall adapter Power Supply provided with the device. All charging circuitry is contained within the main body unit itself.

An ascending sequence of beeps informs the customer the Trinity ELE is ready for

Carol Cole Company Trinity ELE Device 510(k) Submission 510(k) Summary

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use. When the user turns off the device, a descending tone is emitted.

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 output by pressing the + or - intensity buttons to increase or decrease the micro-current output.

COMPLIANCE DATA

The Trinity ELE was tested and found to conform with the FDA's performance Standards set forth in 21 CFR §898.

The Trinity ELE was also tested and found to be in compliance with IEC 60601-1-2 for radiated and power line conducted emissions. The Trinity ELE was evaluated and found to be in compliance with IEC 60601-1 for Electrical Safety.

SUBSTANTIAL EQUIVALENCE

The Trinity ELE has the same intended use and indications for use as the predicate device. The device also has similar 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 Trinity ELE is based on an assessment of non-clinical performance. This assessment included a comparison of the output of the Trinity ELE to that of the predicate. The output performance testing included:

1. Waveform type (e.g., pulsed monophasic, biphasic)
Waveform Shape (e.g., rectangular, spike, rectified sinusoidal) 2.
Maximum Output Voltage 3.
1. Maximum Output Current
Output Tolerance 5.
1. Puise Width
1. Output Frequency
1. Maximum Phase Charge
Maximum Current Density თ

Maximum Power Density (using smallest electrode conductive surface area)

1. Burst Mode (i.e., pulse trains)
- a. Pulses per burst
- b. Pulses per second
- c. Burst duration
- d. Duty Cycle
1. ON Time
1. OFF 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
1. Waveform Shape is identical to the predicate
1. Maximum Output Voltage is less than the predicate due to maintaining the Maximum Current Density is identical to the predicate
1. Maximum Output Current is less than the predicate due to maintaining the

Carol Cole Company Trinity ELE Device 510(k) Submission 510(k) Summary

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Maximum Current Density identical to the predicate

Output Tolerance is identical to the predicate റ്റ്
1. Pulse Width is identical to the predicate
Output Frequency is identical to the predicate 7.
1. Maximum Phase Charge is less than the predicate due to maintaining the Maximum Current Density is identical to the predicate
ഗ് Maximum Current Density is identical to the predicate
1. Maximum Power Density is less than the predicate due to maintaining the Maximum Current Density is identical to the predicate
1. Burst Mode (i.e., pulse trains)
- a. Pulses per burst is identical to the predicate
- b. Pulses per second is identical to the predicate
- Burst duration is identical to the predicate c.
- Duty Cvcle is identical to the predicate o
1. ON Time is identical to the predicate

OFF Time is identical to the predicate

The dual spheres of the Trinity ELE are smaller in size than the predicate to allow optimal contact with smaller areas of the face. To maintain the Maximum Current Density with these smaller spheres identical to the predicate with larger spheres, the output current was reduced corresponding to the reduced contact area. As a result, the Maximum Output Voltage, Maximum Output Current, Maximum Phase Charge, and Maximum Power Density were correspondingly reduced.

The results support a determination of substantial equivalence in that the smaller spheres of the Trinity ELE treat a smaller area of the face with the same Current Density as the predicate.

Carol Cole Company Trinity ELE Device 510(k) Submission 510(k) Summary

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Section 1: Device Descriptions

Section 1: DeviceDescriptions	Trinity ELE DeviceNew Device	NuFACE® TrinityPredicate Device
1. 510(k) Number	K131251	K103472
2. Regulation Number	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 for Use	Over-the-Counter Cosmetic Use	Over-the-Counter Cosmetic Use
8. TechnologicalCharacteristics	The Trinity ELE is an over-the-counter facialstimulation device. The chrome plated dual spheresof the Trinity ELE are designed to gently glide overthe skin to deliver low-level electrical impulses tostrategic locations on the face. The Trinity ELEprobes are designed for optimal contact with smallersurface areas of the face.The Trinity ELE microcurrent continually alternatesbetween the positive and negative probes, and allowsthe user to adjust settings from approximately 53 to192 microamps for a personalized comfort level.The Trinity ELE device measures 2.8" W x 6.2" L x1.3" D. Its outer case is injection molded ofthermoplastic resin. The device comes with aCharging Cradle, which measures 3.1" W x 4.0" L x3.3" D, to charge the internal batteries of the mainbody when not in use. The Charging Cradle ispowered by DC power from a pre-approved walladapter Power Supply provided with the device. Allcharging circuitry is contained within the main bodyunit itself.To turn the device on, the on/off button is pressed.An ascending sequence of beeps and one to five blueLED lights illuminate indicating the unit is ready foruse. Users then follow the instructions for use. TheTrinity ELE requires the use of a conductive gel ormedium. The user can also adjust output level bypressing the + or - intensity buttons to increase ordecrease the microcurrent output.To promote proper use and feedback to the user, theTrinity ELE beeps to cue the user to relocate thedevice after approximately 5 seconds of treatment.When the user turns off the device, a descending toneis emitted.	The NuFACE® Trinity is an over-the-counterfacial toning device. The chrome plated dualspheres of the NuFACE® Trinity are designed togently glide over the skin to deliver low-levelelectrical impulses to strategic locations on theface. The NuFACE® Trinity probes are designedfor optimal contact with the face.The NuFACE® Trinity microcurrent continuallyalternates between the positive and negativeprobes, and allows the user to adjust settingsfrom approximately 0 to 400 microamps for apersonalized comfort level.The NuFACE® Trinity device measures 2.8" Wx 5.1" L x 1.3" D Its outer case is injectionmolded thermoplastic resin. The device comeswith a Charging Cradle, which measures 3.1" Wx 4.0" L x 3.3" D, to charge the internal batteriesof the main body when not in use. The ChargingCradle is powered by DC power from a pre-approved wall adapter Power Supply providedwith the device. All charging circuitry iscontained within the main body unit itself.To turn the device on, the on/off button ispressed. An ascending sequence of beeps andone to five blue LED lights illuminate indicatingthe unit is ready for use. Users then follow theinstructions for use. The NuFACE® Trinitydevice requires the use of a conductive gel ormedium. The user can also adjust output level bypressing the + or - intensity buttons to increaseor decrease the microcurrent output.To promote proper use and feedback to the user,the NuFACE® Trinity 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.
Section 2: Basic UnitCharacteristics	Trinity ELE DeviceNew Device.	NuFACE® TrinityPredicate Device
1. 510(k) Number	K131251	K103472
2. Device Name, Model	Trinity ELE Device	NuFACE® Trinity
3. Manufacturer	Carol Cole Company (CCC)	Carol Cole Company (CCC)
4. Power Source(s)
a. Method of Line CurrentIsolation	4 rechargeable AA NiMHbatteries	4 rechargeable AA NiMHbatteries
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 circuitdesign
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?	EN 60601-1EN 60601-1-2	EN 60601-1EN 60601-1-2
16. Compliance with 21 CFR898?	Yes	Yes
17. Weight	9 oz without charging base	9 oz without charging base
18. Dimensions of device(inch)[W x L x D]	2.8" W x 6.2" L x 1.3" D	2.8" W x 5.1" L x 1.3" D
19: Dimensions of charging Unit(inch) [W x L x D]	3.1" W x 4.0" L x 3.3" D	3.1" W x 4.0" L x 3.3" D
19. Housing Materials andConstruction	Thermo Plastic	Thermo Plastic

Trinity ELE and NuFACE® Trinity Device Comparison Table

Carol Cole Company 510(k) Summary

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Section 2: Basic Unit Characteristics

Trinity ELE and NuFACE® Trinity Device Substantial Equivalence Comparison Table

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Section 3: Output Specifications

Trinity ELE and NuFACE® Trinity Device Substantial Equivalence Comparison
Table

Section 3: Output Specifications	Trinity ELE DeviceNew Device	NuFACE® Trinity-Predicate Device
Waveform (e.g., pulsed monophasic, biphasic)	Pulsed Biphasic	Pulsed Biphasic
Shape (e.g., rectangular, spike, rectified sinusoidal)	Modulated Square	Modulated Square
Maximum Output Voltage (specify units)	96 mV @ 500 Ω	137 mV @ 500 Ω
	384 mV @ 2 kΩ	769 mV @ 2 kΩ
	1.92 V @ 10 kΩ	3.82 V @ 10 kΩ
Maximum Output Current (specify units)	193 μA @ 500 Ω	274 μA @ 500 Ω
	1193 μA @ 2 kΩ	387 μA @ 2 kΩ
	192 μA @ 10 kΩ	383 μA @ 10 kΩ
Output Tolerance	+/- 5%	+/- 2%
Pulse Width (specify units)	60 ms	60 ms
Frequency (Hz)	8.33 Hz	8.33 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 Determined	Not Determined
Net Charge (µC per pulse)	N/A - Battery Operated	N/A - Battery Operated
Maximum Phase Charge (µC)	11.5 µC @ 500 Ω	23.9 µC @ 500 Ω
Maximum Current Density (mA/cm²)	0.739 mA/cm² @ 500 Ω	0.518 mA/cm² @ 500 Ω
Maximum Power Density (µW/cm²)(using smallest electrode conductive surface area)	1420 µW/cm² @ 500 Ω	1423 µW/cm² @ 500 Ω
Burst Mode (i.e., pulse trains)
a. Pulses per burst	20	20
b. Pulses per second	8.3	8.3
c. Burst duration (seconds)	2.4	2.4
d. Duty Cycle [Line (b) x Line (c)](on time per burst)	20	20
ON Time (seconds)	Constant	Constant
OFF Time (seconds)	None	None

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Image /page/6/Picture/0 description: The image shows a 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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002

October 1, 2013

Carol Cole Company c/o Ms. Rand Daoud Compliance Specialist 1325 Sycamore Ave, Suite A Vista, CA 92081

Re: K131251

Trade/Device Name: Trinity ELE Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO Dated: August 28, 2013 Received: August 29, 2013

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 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 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.

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Page 2 - Ms. Rand Daoud

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 Small Manufacturers, International and Consumer Assistance 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,

Joyce M. Whang -S

Victor Krauthamer, Ph.D. for Acting 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): K131251

Device Name: Trinity ELE

Indications For Use:

The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21 CFR 807 Subpart C).

Prescription Use (Part 21 CFR 801 Subpart D)

the state of the state of the state of the states and

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ x (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ·

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).