(153 days)
Not Found
No
The device description and performance studies focus on electrical stimulation parameters and user-adjustable settings, with no mention of AI or ML capabilities.
No
The device is described as being for "cosmetic use" and is not indicated for treating any disease or medical condition, which aligns with the definition of a cosmetic device rather than a therapeutic one.
No
The device is described as an over-the-counter cosmetic device intended for facial stimulation to increase facial contour and firm skin and muscles, not for diagnosing any medical condition.
No
The device description explicitly details physical hardware components including dual spheres, an outer case made of thermoplastic resin, a charging cradle, and a wall adapter power supply. It also describes physical interactions like pressing buttons to adjust output and audio beeps.
Based on the provided text, the Trinity ELE is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "facial stimulation" for "over-the-counter cosmetic use." This is a physical application to the body for cosmetic purposes, not a test performed on samples taken from the body to diagnose or monitor a medical condition.
- Device Description: The description details a device that applies micro-current to the skin for facial contouring and firming. This aligns with a physical therapy or cosmetic device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Diagnosing or monitoring diseases or conditions
- Using reagents or assays
The device's function is to stimulate facial muscles and skin externally, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (21 CFR 801 Subpart C).
Product codes (comma separated list FDA assigned to the subject device)
NFO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The anatomical site for application of the Trinity ELE is 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)
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.
The results are provided in Section 3 (Output Specifications) below. As shown in the Substantial Equivalence Comparison Table:
- Waveform type is identical to the predicate
- Waveform Shape is identical to the predicate
- Maximum Output Voltage is less than the predicate due to maintaining the Maximum Current Density is identical to the predicate
- Maximum Output Current is less than the predicate due to maintaining the Maximum Current Density identical to the predicate
- Output Tolerance is identical to the predicate
- Pulse Width is identical to the predicate
- Output Frequency is identical to the predicate
- Maximum Phase Charge is less than the predicate due to maintaining the Maximum Current Density is identical to the predicate
- Maximum Current Density is identical to the predicate
- Maximum Power Density is less than the predicate due to maintaining the Maximum Current Density is identical to the predicate
- Burst Mode (i.e., pulse trains)
- Pulses per burst is identical to the predicate
- Pulses per second is identical to the predicate
- Burst duration is identical to the predicate
- Duty Cycle is identical to the predicate
- ON Time is identical to the predicate
- OFF Time is identical to the predicate
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
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 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
Carol Cole Company Trinity ELE Device 510(k) Submission 510(k) Summary
1
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:
-
- Waveform type (e.g., pulsed monophasic, biphasic)
- Waveform Shape (e.g., rectangular, spike, rectified sinusoidal) 2.
- Maximum Output Voltage 3.
-
- Maximum Output Current
- Output Tolerance 5.
-
- Puise Width
-
- Output Frequency
-
- Maximum Phase Charge
- Maximum Current Density თ
- Maximum Power Density (using smallest electrode conductive surface area)
-
- Burst Mode (i.e., pulse trains)
- a. Pulses per burst
- b. Pulses per second
- c. Burst duration
- d. Duty Cycle
-
- ON Time
-
- OFF Time
The results are provided in Section 3 (Output Specifications) below. As shown in the Substantial Equivalence Comparison Table:
-
- Waveform type is identical to the predicate
-
- Waveform Shape is identical to the predicate
-
- Maximum Output Voltage is less than the predicate due to maintaining the Maximum Current Density is identical to the predicate
-
- Maximum Output Current is less than the predicate due to maintaining the
Carol Cole Company Trinity ELE Device 510(k) Submission 510(k) Summary
2
Maximum Current Density identical to the predicate
- Output Tolerance is identical to the predicate റ്റ്
-
- Pulse Width is identical to the predicate
- Output Frequency is identical to the predicate 7.
-
- 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
-
- Maximum Power Density is less than the predicate due to maintaining the Maximum Current Density is identical to the predicate
-
- 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
-
- 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
3
Section 1: Device Descriptions
| Section 1: Device
Descriptions | Trinity ELE Device
New Device | NuFACE® Trinity
Predicate 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. Technological
Characteristics | The Trinity ELE is an over-the-counter facial
stimulation device. The chrome plated dual spheres
of the Trinity ELE are designed to gently glide over
the skin to deliver low-level electrical impulses to
strategic locations on the face. The Trinity ELE
probes are designed for optimal contact with smaller
surface areas of the face.
The Trinity ELE microcurrent 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 device 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.
To turn the device on, the on/off button is pressed.
An ascending sequence of beeps and one to five blue
LED lights illuminate indicating the unit is ready for
use. Users then follow the instructions for use. The
Trinity ELE requires the use of a conductive gel or
medium. The user can also adjust output level by
pressing the + or - intensity buttons to increase or
decrease the microcurrent output.
To promote proper use and feedback to the user, the
Trinity ELE beeps to cue the user to relocate the
device after approximately 5 seconds of treatment.
When the user turns off the device, a descending tone
is emitted. | The NuFACE® Trinity is an over-the-counter
facial toning device. The chrome plated dual
spheres of the NuFACE® Trinity are designed to
gently glide over the skin to deliver low-level
electrical impulses to strategic locations on the
face. The NuFACE® Trinity probes are designed
for optimal contact with the face.
The NuFACE® Trinity microcurrent continually
alternates between the positive and negative
probes, and allows the user to adjust settings
from approximately 0 to 400 microamps for a
personalized comfort level.
The NuFACE® Trinity device measures 2.8" W
x 5.1" L x 1.3" D Its outer case is injection
molded 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.
To turn the device on, the on/off button is
pressed. An ascending sequence of beeps and
one to five blue LED lights illuminate indicating
the unit is ready for use. Users then follow the
instructions for use. The NuFACE® Trinity
device requires the use of a conductive gel or
medium. The user can also adjust output level by
pressing the + or - intensity buttons to increase
or decrease the microcurrent output.
To promote proper use and feedback to the user,
the NuFACE® Trinity beeps to cue the user to
relocate the device after approximately 5 seconds
of treatment. When the user turns off the device,
a descending tone is emitted. |
| Section 2: Basic Unit
Characteristics | Trinity ELE Device
New Device. | NuFACE® Trinity
Predicate 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 Current
Isolation | 4 rechargeable AA NiMH
batteries | 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 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 |
| 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 Voluntary
Standards? | EN 60601-1
EN 60601-1-2 | EN 60601-1
EN 60601-1-2 |
| 16. Compliance with 21 CFR
898? | 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 and
Construction | Thermo Plastic | Thermo Plastic |
Trinity ELE and NuFACE® Trinity Device Comparison Table
Carol Cole Company 510(k) Summary
4
Section 2: Basic Unit Characteristics
Trinity ELE and NuFACE® Trinity Device Substantial Equivalence Comparison Table
5
Section 3: Output Specifications
| Trinity ELE and NuFACE® Trinity Device Substantial Equivalence Comparison | |||
|---|---|---|---|
| Table |
| Section 3: Output Specifications | Trinity ELE Device
New 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 |
6
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.
7
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
8
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 ____________________________________________________________________________________________________________________________________________________________________