(113 days)
The NuFACE Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter use.
The NuFACE® Mini Device is an over- the- counter facial and neck toning device. The chrome plated dual spheres of the NuFACE® Mini are designed to gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face and neck. The NuFACE® Mini electrodes are designed for optimal contact with the face.
The NuFACE® Mini microcurrent continually alternates between the positive electrodes and allows the user to adjust settings.
The NuFACE® Mini Device measures approximately 2.5" W x 4.2" D. Its outer case is injection mold thermoplastic resin. The device comes with an external Power Supply to recharge the lithium ion battery of the device when not in use. The external Power Supply is a pre- approved wall adapter. All charging circuitry is contained within the device itself.
This document is a 510(k) Premarket Notification for the NuFACE Mini Device. It aims to demonstrate substantial equivalence to a predicate device, the NuFACE Trinity Device, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding study design, sample sizes, expert ground truth establishment, and comparative effectiveness studies is not present in this type of submission.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
Since this filing is for substantial equivalence, the "acceptance criteria" are primarily established by the characteristics and performance of the predicate device (NuFACE Trinity). The reported device performance for the NuFACE Mini is presented as a comparison to the predicate.
| Characteristic | Acceptance Criteria (Predicate: NuFACE Trinity) | Reported Device Performance (NuFACE Mini) | Met/Comparable |
|---|---|---|---|
| Regulatory | |||
| Regulation Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 | Met (Same) |
| Regulation Name | Transcutaneous electrical nerve stimulator for pain relief | Transcutaneous electrical nerve stimulator for pain relief | Met (Same) |
| Regulatory Class | Class II | Class II | Met (Same) |
| Product Code | NFO | NFO | Met (Same) |
| Intended Use | Facial and neck stimulation for over-the-counter cosmetic use | Facial and neck stimulation for over-the-counter cosmetic use | Met (Same) |
| Indications for Use | Over-the-Counter Cosmetic Use | Over-the-Counter Cosmetic Use | Met (Same) |
| Anatomic Sites | Face and Neck | Face and Neck | Met (Same) |
| Technological Characteristics | |||
| Form Factor (General) | Handheld, dual spherical electrodes, microcurrent | Handheld, dual spherical electrodes, microcurrent | Comparable (Same general design principles) |
| Waveform | Pulsed Biphasic | Pulsed Biphasic | Met (Same) |
| Shape | Modulated Square | Modulated Square | Met (Same) |
| Max Output Voltage | 28 VDC | 28 VDC | Met (Same) |
| Max Output Current | $400 \mu A$ at 500 Ω | $348 \mu A$ at 500 Ω | Comparable (Slightly lower, but within expected range for similar devices/intended use, and not clinically significant for this type of equivalence claim) |
| Max Output Current Density | 0.419 mA/cm² | 0.452 mA/cm² | Comparable (Slightly higher, but within expected range for similar devices/intended use, and not clinically significant for this type of equivalence claim) |
| Output Current (not stimulating) | < 1 μΑ | < 1 μΑ | Met (Same) |
| Output Tolerance | +/- 10% | +/- 5% | Met (Improved) |
| Pulse Width | 60 msec | 60 msec | Met (Same) |
| Frequency (Hz) | Approximately 8.3 Hz | Approximately 8.3 Hz | Met (Same) |
| Beat Frequency | No Beat Frequency | No Beat Frequency | Met (Same) |
| Burst Mode - Pulses per burst | 20 | 20 | Met (Same) |
| Burst Mode - Pulses per second | 8.3 | 8.3 | Met (Same) |
| Burst Mode - Burst duration | 2.4 s | 2.4 s | Met (Same) |
| Burst Mode - Duty Cycle | 50% | 50% | Met (Same) |
| ON Time | 60 msec | 60 msec | Met (Same) |
| OFF Time | 60 msec | 60 msec | Met (Same) |
| Power Source | Internal rechargeable Lithium ion battery | Internal rechargeable Lithium ion battery | Met (Same) |
| Line Current Isolation | Type BF | Type BF | Met (Same) |
| Patient Leakage Current | N/A - Battery operated | N/A - Battery operated | Met (Same) |
| External Power Adapter | NuFACE 7-volt power adapter | NuFACE 5-volt power adapter | Comparable (Different voltage, but functionality and safety verified through standards compliance) |
| Number of Output Channels | 1 | 1 | Met (Same) |
| Regulated Current or Voltage | Both | Both | Met (Same) |
| Software/Firmware/Microprocessor | Yes | Yes | Met (Same) |
| Automatic Overload Trip | Not required due to circuit design | Not required due to circuit design | Met (Same) |
| Automatic No-Load Trip | Yes | Yes | Met (Same) |
| Automatic Shut Off | Yes (20 minutes) | Yes (5 minutes) | Comparable (Difference in timing, but both include shut-off for safety/usage. Not a critical difference for equivalence) |
| Patient Override Control | Yes | Yes | Met (Same) |
| Indicator Display | On/Off, Low Battery, Voltage/Current Level | On/Off, Low Battery, Voltage/Current Level | Met (Same) |
| Compliance with Voluntary Standards | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11 | Met (Same, with additional relevant standards cited for the proposed device) |
| Compliance with 21 CFR 898 | Yes | Yes | Met (Same) |
| Weight | 9 oz. without charging base | 6 oz. | Comparable (Different, but lighter weight for a 'mini' version is expected and not adverse to safety/effectiveness for intended use) |
| Dimensions | 2.8" x 5.1" x 1.3" | 2.5" x 4.2" x 1.2" | Comparable (Different, 'mini' implies smaller, not adverse) |
| Housing Materials | Thermoplastic | Thermoplastic | Met (Same) |
| Biocompatibility | User contacting materials tested and shown biocompatible | User contacting materials identical to predicate, previously tested and shown biocompatible | Met (Same) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical "test set" in the context of efficacy or clinical performance. The comparison provided is a technical comparison to a predicate device. Performance testing was conducted for safety and EMC standards compliance, but details on sample size for these engineering tests are not provided and typically not part of the 510(k) summary for such devices. There is no information on data provenance related to clinical outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" establishment by medical experts is described, as this is a technical equivalence review against a predicate device and relevant safety standards, not a clinical efficacy study requiring interpretation of outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described as there is no clinical test set requiring expert consensus.
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
Not applicable. This device is a transcutaneous electrical nerve stimulator for cosmetic use (facial and neck toning), not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies and AI assistance comparisons are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware product for direct user application, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is effectively the established safety and performance characteristics of the legally marketed predicate device (NuFACE Trinity) and compliance with recognized safety and EMC standards. The proposed device is demonstrating that its technical specifications and safety parameters are either identical or acceptably similar and safe compared to the predicate.
8. The sample size for the training set
Not applicable. This document does not describe a machine learning or AI algorithm that would require a training set.
9. How the ground truth for the training set was established
Not applicable.
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October 15, 2019
Carol Cole Company dba NuFACE Nadia Miller Regulatory Affairs Specialist 1325 Sycamore Avenue, Suite A Vista, California 92081
Re: K191672
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: August 16, 2019 Received: August 16, 2019
Dear Nadia Miller:
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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
For Vivek Pinto Division Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191672
Device Name
NuFACE Mini Device
Indications for Use (Describe)
The NuFACE Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter 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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NUFACE
NuFACE Mini Device 510(K) Summary
Date Prepared: June 20, 2019
510(к) Submitter/ Owner
Carol Cole Company dba NuFACE 1325 Sycamore Ave, Suite A Vista, CA 92081, USA
Contact Information
Nadia Vazirzadeh Miller- Regulatory Affairs Specialist Phone: (760) 509-1259 Facsimile: (760) 650-3124 Email: nvazirzadeh@mynuface.com
Device Names
Device Trade/ Proprietary Name: Device Common or Usual Name: Classification Name: Regulation Number: Product Code:
NuFACE Mini Facial and Neck Skin Toning Device NuFACEMini Device Transcutaneous electrical nerve stimulator for pain relief 21 CFR 882.5890 NFO
Predicate Device
The legally marketed predicate device to which the Carol Cole Company is claiming equivalence for over-thecounter use:
| 510(k) Number: | K181008 |
|---|---|
| Manufacturer: | Carol Cole Company dba NuFACE |
| Trade Name: | NuFACE Trinity Device |
| Product Code: | NFO |
Device Description
The NuFACE® Mini Device is an over-the- counter facial and neck toning device. The chrome plated dual spheres of the NuFACE® Mini are designed to gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face and neck. The NuFACE® Mini electrodes are designed for optimal contact with the face.
The NuFACE® Mini microcurrent continually alternates between the positive electrodes and allows the user to adjust settings.
The NuFACE® Mini Device measures approximately 2.5" W x 4.2" D. Its outer case is injection mold thermoplastic resin. The device comes with an external Power Supply to recharge the lithium ion battery of the device when not in use. The external Power Supply is a pre- approved wall adapter. All charging circuitry is contained within the device itself.
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NUFA
To turn the device on/off, the power/control 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® Mini Device requires the use of a conductive gel or medium during treatment. The user can also adjust the output level by briefly pressing the power/control button to rotate between three microcurrent output levels. A long press of this button toggles the device on and off.
To promote proper use and feedback to the NuFACE® Mini 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.
Intended Use
The NuFACE Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
Technological Characteristics
The NuFACE Mini Device (proposed) is substantially equivalent to that of its NuFACE Trinity (predicate) and its technological characteristics are virtually identical/ equivalent. It produces microcurrent discharged through the two spherical electrodes.
Biocompatability
User contacting materials for NuFACE Mini are identical and manufactured identically to those of the predicate device. All materials were previously tested and shown to be biocompatible.
Performance Standards
The NuFACE Mini Device (proposed) is substantially equivalent to that of its NuFACE Trinity (predicate) and both comply to FDA performance standards set forth in 21 CFR §898. Product Safety and EMC performance testing was conducted for the following aspects:
-
- Electrical and Constructional Safety in accordance with IEC 60601-1
- Electromagnetic Compatibility (EMC) in accordance with IEC 60601-1-2 2.
-
- IEC 60601-2-10
-
- IEC 60601-1-11
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N U F A C E*
Table 1. Device Description Comparison
| Device Description | NUFACE Mini(Proposed) | NUFACE Trinity(Predicate) | Same orDifferentTechnologicalCharacteristics |
|---|---|---|---|
| 1. 510(k) Number | TBD | K181008 | - |
| 2. Regulation Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 | Same |
| 3. Regulation Name | Transcutaneous electrical nervestimulator for pain relief | Transcutaneous electrical nervestimulator for pain relief | Same |
| 4. Regulatory Class | Class II | Class II | Same |
| 5. Device ClassificationName | Stimulator, Transcutaneous Electrical,Aesthetic Purposes | Stimulator, Transcutaneous Electrical,Aesthetic Purposes | Same |
| 6. Product Code | NFO | NFO | Same |
| 7. Regulation MedicalSpecialty | Neurology | Neurology | Same |
| 8. Intended Use | NuFACE Mini Device is intended for facialand neck stimulation and is indicated forover-the- counter cosmetic use. | NuFACE Trinity Device is intended forfacial and neck stimulation and isindicated for over-the-countercosmetic use. | Same |
| 9. Indications for Use | Over-the-Counter Cosmetic Use | Over-the-Counter Cosmetic Use | Same |
| 10. Anatomic Sites | Face and Neck | Face and Neck | Same |
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NUFACE®
- Technological Characteristics
The NuFACE® Mini Device is an over-thecounter facial and neck toning device. The chrome plated dual spheres of the NuFACE® Mini are designed to gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face and neck. The NuFACE® Mini electrodes are designed for optimal contact with the face.
The NuFACE® Mini microcurrent continually alternates between the positive and negative electrodes and allows the user to adjust settings.
The NuFACE® Mini device measures approximately 2.5" W x 4.2" L x 1.2" D. Its outer case is injection mold thermoplastic resin. The device comes with an external Power Supply to recharge the lithium ion battery of the device when not in use. The external Power Supply is a pre- approved wall adapter. All charging circuitry is contained within the device itself.
To turn the device on/off, the power/control 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® Mini Device requires the use of a conductive gel or medium during treatment. The user can also adjust the output level by briefly pressing the power/control button to rotate between three microcurrent output levels. A long press of this button toggles the device on and off. To promote proper use and feedback to the user, the NuFACE® Mini 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 Device is an overthe-counter facial and neck toning device. Its outer case is injection molded thermoplastic resin. The output contacts consist of chromeplated spheres. The device is powered by a rechargeable lithium ion battery and produces a microcurrent that is discharged through two fixed, smooth electrode spheres. To turn the device on, the on/off button is pressed. Ascending tonal beeps indicate the device is on. One to five red LED lights illuminate indicating the output intensity level and the unit is ready for use. Users then follow the instructions for use. The two spheres gently glide over the skin to deliver low-level electrical impulses to targeted locations. The NuFACE Trinity spheres are designed for optimal contact with the skin. The NuFACE Trinity device delivers microcurrent as a constant biphasic square wave comprising a (10) positive pulses followed by (10) negative pulses. The microcurrent output continuously alternates between the positive and negative electrode spheres and allows the user to adjust the output for a personalized comfort level. The NuFACE Trinity requires the use of a conductive gel. To promote proper use and provide feedback to the user, the NuFACE Trinity beeps to cue the user to relocate the device approximately every 5 seconds.
Same
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NUFACE®
Table 2. Basic Unit Characteristics Comparison
| Basic Unit Characteristics | NUFACE Mini(Proposed) | NUFACE Trinity(Predicate) | Same or DifferentTechnologicalCharacteristics |
|---|---|---|---|
| 1. 510(k) Number | TBD | K181008 | |
| 2. Device Name, Model | NuFACE Mini | NuFACE Trinity | |
| 3. Manufacturer | Carol Cole Company dbaNuFACE | Carol Cole Company dbaNuFACE | Same |
| 4. Power Source(s) | Internal rechargeable Lithiumion battery | Internal rechargeableLithium ion battery | Same |
| a. Method of Line CurrentIsolation | Type BF | Type BF | Same |
| b. Patient Leakage Current | |||
| 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 |
| 5. External power adapter | NuFACE 5-voltpower adapter | NuFACE 7-voltpower adapter | Same |
| 6. Number of Output Channels | । | । | 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 |
| 7. Regulated Current or Regulated Voltage | Both | Both | Same |
| 8. Software/Firmware/Microprocessor Control | Yes | Yes | Same |
| 9. Automatic Overload Trip | Not required due to circuitdesign | Not required due tocircuit design | Same |
| 10. Automatic No- Load Trip | Yes | Yes | Same |
| 11. Automatic Shut Off | Yes | Yes | Same |
| 12. Patient Override Control | Yes | Yes | Same |
| 13. Indicator Display | |||
| a. On/Off Status | Yes | Yes | Same |
| b. Low Battery | Yes | Yes | Same |
| c. Voltage/Current Level | Yes | Yes | Same |
| 14. Automatic Shut- Off (minutes) | Yes (5 minutes) | Yes (20 minutes) | Same |
| 15. Compliance with VoluntaryStandards | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | Same |
| 16. Compliance with 21 CFR 898 | Yes | Yes | Same |
| 17. Weight | 6 oz. | 9 oz. without charging base | Same |
| 18. Dimensions of device(inch) [W x L x D] | 2.5" x 4.2" x 1.2" | 2.8" x 5.1" x 1.3" | Same |
| 19. Housing Materials and Construction | Thermoplastic | Thermoplastic | Same |
| Output Specifications | NUFACE Mini(Proposed) | NUFACE Trinity(Predicate) | Same or DifferentTechnologicalCharacteristics |
| 1. 510(k) Number | TBD | K181008 | - |
| 2. Waveform (e.g., pulsed monophasic,biphasic) | Pulsed Biphasic | Pulsed Biphasic | Same |
| 3. Shape (e.g., rectangular, spike,rectified sinusoidal) | Modulated Square | Modulated Square | Same |
| 4. Maximum Output Voltage | 28VDC | 28 VDC | Same |
| 5. Maximum Output Current | $348 \mu A$ at 500 Ω | $400 \mu A$ at 500 Ω | Same |
| 6. Maximum Output CurrentDensity | 0.452 mA/cm² | 0.419 mA/cm² | Same |
| 7. Output Current when not stimulating | < 1 μΑ | < 1 μΑ | Same |
| 8. Output Tolerance | +/- 5% | +/- 10% | Same |
| 9. Pulse Width (specify units) | 60 msec | 60 msec | Same |
| 10. Frequency (Hz) | Approximately 8.3 Hz | Approximately 8.3 Hz | Same |
| 11. For interferential modes, only | - | - | - |
| 12. Beat Frequency (Hz) | No Beat Frequency | No Beat Frequency | Same |
| 13. For multiphasic waveforms, only | - | - | - |
| 14. Symmetrical phases | Not Multiphasic | Not Multiphasic | Same |
| 15. Phase Duration (include units) | Not Multiphasic | Not Multiphasic | Same |
| 16. Net Charge (µC per pulse) | N/A - Battery operated | N/A - Battery operated | Same |
| 17. Burst Mode (i.e., pulse trains) | - | - | - |
| a. Pulses per burst | 20 | 20 | Same |
| b. Pulses persecond | 8.3 | 8.3 | Same |
| c. Burst duration (seconds) | 2.4 s | 2.4 s | Same |
| d. Duty Cycle | 50% | 50% | Same |
| 18. ON Time(seconds) | 60 msec | 60 msec | Same |
| 19. OFF Time (seconds) | 60 msec | 60 msec | Same |
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NUFACE®
Table 3. Output Specifications Comparison
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NUFACE
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR part 807, and based on the relative information provided in this premarket notification, we conclude the NuFACE Mini Device is substantially equivalent to the NuFACE Trinity Device with regards to safety and effectiveness.
§ 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).