(60 days)
The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.
The BEAGANK 4T PLUS is a cosmetic device which is intended for use on the face and body skin. The device contains a rechargeable lithium ion battery and is provided with a charger. The device has four electrode metal pads on the head that deliver electrical impulses to the face and body skin and provide four different operational modes. The device operates by applying Transcutaneous Electrical Nerve Stimulation to the face and body skin. The electrodes that are positioned on the skin must be covered with a wet cotton pad. Purified water or commercially available cosmetic formulation liquid can be used as a conductive media to generate the electric pulses. Two attachments are provided with the BEAGANK 4T PLUS: Scalp attachment, Small attachment.
The provided document is a 510(k) summary for the Beagank 4T Plus device. It does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with safety standards. It explicitly states: "No new clinical studies have been submitted as part of this Premarket Notification."
Therefore, I cannot provide the requested information regarding acceptance criteria for clinical performance and a study proving those criteria are met, as such information is not present in the provided text.
However, I can extract information related to non-clinical performance and safety testing which serves as the basis for the FDA clearance in this case.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
Based on the "Summary of Non-Clinical / Test Data," the device performance is demonstrated by compliance with specific safety standards. The "acceptance criteria" here are essentially passing these standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1 (Electrical Safety and Essential Performance) | Complies |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Complies |
| ISO 10993-5 (Biocompatibility - Cytotoxicity) | Complies |
| ISO 10993-10 (Biocompatibility - Irritation and Sensitization) | Complies |
| ISO 10993-23 (Biocompatibility - Irritation for medical devices and in vitro test method for skin irritation) | Complies |
2. Sample size used for the test set and the data provenance:
Not applicable for this type of submission. The tests are for device safety and electrical performance, typically conducted on a sample of the manufactured device. Details on the specific number of units tested and data provenance (country of origin, retrospective/prospective) are not provided in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-clinical safety and performance evaluation, not a clinical study involving expert ground truth for interpretation. The "ground truth" is adherence to established engineering and biocompatibility standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a clinical study.
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:
No. The document explicitly states "No new clinical studies have been submitted." This is not an AI-assisted diagnostic device, and thus no MRMC study would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical electrical stimulation device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" is the established requirements and limits defined within the cited IEC and ISO standards.
8. The sample size for the training set:
Not applicable. There is no machine learning or AI component that would require a training set.
9. How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 21, 2023
Belega Inc. % Nana Nagashita Regulatory Consultant Ken Block Consulting Co., Ltd. 1-9-9 Tsukiji Chuo-ku, Tokyo 104-0045 Japan
Re: K233010
Trade/Device Name: Beagank 4T Plus Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: September 15, 2023 Received: September 22, 2023
Dear Nana Nagashita:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices
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OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233010
Device Name BEAGANK 4T PLUS
Indications for Use (Describe)
The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| Owner/Submitter: | Belega Co., Ltd.1-4-20 Sonezaki Shinchi, Kita-kuOsaka-shi, Osaka, Japan 530-0002 |
|---|---|
| Contact Person: | Ken Block Consulting Co., Ltd.Ms. Nana NagashitaRegulatory consultant1-9-9 Tsukiji, Chuo-kuTokyo, Japan 104-0045TEL: +81-3-6260-6688FAX: +81-3-6260-6689nagashita@kenblockconsulting.com |
| Date Prepared: | September 20, 2023 |
| Submission Type: | Traditional 510(k) |
| Proposed Device | Manufacturer: BELEGA Co., Ltd.Trade Name: BEAGANK 4T PLUSCommon Name: Aesthetic TENS DeviceClassification Name: Transcutaneous Electrical Nerve Stimulator for Pain ReliefProduct Code: NFORegulatory Standard: 21 CFR 882.5890 |
| Predicate Device: | 510(k) Number: K191951Manufacturer: Avazzia, Inc.Trade Name: Avazzia OTC TENS for Aesthetics, model BEST-AV1: EZZI LIFT DeviceCommon Name: Aesthetic TENS DeviceClassification Name: Transcutaneous Electrical Nerve Stimulator for Pain ReliefProduct Code: NFORegulatory Standard: 21 CFR 882.5890 |
| Reference Device: | 510(k) Number: K011935Manufacturer: Salton Inc.Trade Name: Rejuvenique® system, Model RJV-10Common Name: Aesthetic TENS DeviceClassification Name: Transcutaneous Electrical Nerve Stimulator for Pain ReliefProduct Code: NFO, GYB (Media, Conductive)Regulatory Standard: 21 CFR 882.5890, 21 CFR 882.1275 (Media, Conductive) |
| Reference Device: | 510(k) Number: K181008Manufacturer: Carol Cole Company dba NuFACETrade Name: NuFACE TrinityCommon Name: Aesthetic TENS DeviceClassification Name: Transcutaneous Electrical Nerve Stimulator for Pain ReliefProduct Code: NFO |
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BEAGANK 4T PLUS is a cosmetic device which is intended for use on the face and body Device Description: skin. The device contains a rechargeable lithium ion battery and is provided with a charger. The device has four electrode metal pads on the head that deliver electrical impulses to the face and body skin and provide four different operational modes.
The device operates by applying Transcutaneous Electrical Nerve Stimulation to the face and body skin. The electrodes that are positioned on the skin must be covered with a wet cotton pad. Purified water or commercially available cosmetic formulation liquid can be used as a conductive media to generate the electric pulses. Two attachments are provided with the BEAGANK 4T PLUS:
- Scalp attachment -
- Small attachment
Statement of The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic Intended Use: use including facial and neck stimulation or body skin stimulation.
Summary of The major differences between the proposed and predicate devices are summarized in the Technological tables below: Characteristics:
| Table 1: Basic characteristics | |||||
|---|---|---|---|---|---|
| New Device | Predicate Device | Reference Device | Reference Device | ||
| Trade Name | BEAGANK 4TPLUS | EZZI-LIFT Device | Rejuvenique | NuFACE Trinity | |
| 510(k) | K233010 | K191951 | K011935 | K181008 | |
| Indication for Use | The BEAGANK4T PLUS is ahandheld portabledevice for over-the-counteraesthetic useincluding facialand neckstimulation orbody skinstimulation. | The Avazzia OTCTENS foraesthetics, modelBEST-AV1™:EZZI-LIFT™Device is indicatedfor over-the-counter aestheticuse includingfacial and neckstimulation orbody skinstimulation. | Rejuveniquesystem is indicatedfor cosmetic use. | The NuFACETrinity is intendedfor facial and neckstimulation and isindicated for over-the-countercosmetic use. | |
| Device Class | Class II | Class II | Class II | Class II | |
| Operating Power | InternalrechargeableLithium-ionbattery | Two 1.5 V AAbatteries | 9 V battery | InternalrechargeableLithium-ionbattery | |
| Method of Line CurrentIsolation | Type BF | Unknown | Unknown | Type BF | |
| PatientLeakageCurrent | Normal | DC: <1μΑAC: <1μΑTested per IEC60601-1 | Unknown | Unknown | N/A - Batteryoperated |
| Singlefault | DC: <1μΑAC: <1μΑTested per IEC60601-1 | Unknown | Unknown | N/A - Batteryoperated | |
| Ave. DC currentthrough electrodeswhen device is on butno pulse are beingapplied (μΑ) | <1μΑ | Unknown | Unknown | Unknown | |
| OutputChannels | MethodofChannelIsolation | N/A - 1 outputchannel | Unknown | Electrode groupselected by relays | N/A - 1 outputchannel |
| Regulated Current orRegulated Voltage | Voltage | Unknown | Voltage | Both | |
| Automatic OverloadTrip | Not required dueto circuit design | Unknown | No | Not required dueto circuit design | |
| Automatic No-LoadTrip | Not required dueto circuit design | Unknown | No | Yes | |
| Automatic Shut Off | Yes | Yes | Yes | Yes | |
| Patient OverrideControl | Yes | Unknown | Yes | Yes | |
| Weight | 136g | 153g(5.4 ounces) | 80 g | 9 oz. withoutcharging base | |
| Number of outputmodes | 4 modes:maximum 5minutes each | 4 modes: 60minutes | 1 | Unknown | |
| Low Battery Indicator | Yes | Yes | Yes | Yes | |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | |
| Electrical safety | IEC 60601-1Medicalelectricalequipment -Part 1 Generalrequirementsfor basicsafety andessentialperformanceIEC 60601-1-2Medicalelectrical | IEC 60601-1Medicalelectricalequipment -Part 1 Generalrequirementsfor safetyIEC 60601-1-2Medicalelectricalequipment -Part 1-2:General | Unknown | IEC 60601-1IEC 60601-1-2 | |
| Part 1-2:Generalrequirementsfor basicsafety andessentialperformance –CollateralStandard:Electromagnetic disturbances–Requirementsand tests | for basicsafety andessentialperformance –CollateralStandard:Electromagnetic disturbances–Requirementsand testsIEC 60601-2-10 medicalelectricalequipment –Part 2:10;Particularrequirementsfor the safetyof nerve andmusclestimulators | ||||
| Housing Materials andConstruction | ABS | PCBs insideplastic casehousing | ABS Plastic, snaplatch assembly | Thermoplastic | |
| Accessories | Small and Scalpattachment | Built-in, Y, Brush,Pencil | Unknown | Unknown |
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Table 2: Technological Characteristics
| Output Specifications: Mode 1 | ||||
|---|---|---|---|---|
| New Device | Predicate Device | Reference Device | Reference Device | |
| Trade Name | BEAGANK 4TPLUS | EZZI-LIFT Device | Rejuvenique | NuFACE Trinity |
| Indications for Use | The BEAGANK 4TPLUS is a handheldportable device forover-the-counteraestheticuseincluding facial andneck stimulation orbodyskinstimulation. | The Avazzia OTCTENS for aesthetics,modelBEST-AV1TM:EZZI-LIFTTM Device isindicated for over-the-counter aestheticuse including facialand neck stimulationor bodyskinstimulation. | Rejuvenique systemis indicatedforcosmetic use. | The NuFACETrinity is intendedfor facial and neckstimulation and isindicated for over-the-counter cosmeticuse. |
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| Waveform Shape | Rectangle, biphasic asymmetric | Positive square wave followed by a damped sinusoidal waveform of variable duration depending on damping and body loading | Pulsed biphasic, Rectangular (+phase), Spike (- phase) | Pulsed biphasic modulated square wave |
|---|---|---|---|---|
| Max output voltage | (+/-15%) | (+/-20%) | (+/-10%) | 28VDC |
| @ 500Ω | 127mV (0.12V) | -42V | 18.8V | not publicly available |
| @2kΩ | 515mV (0.51V) | -122V | 24.8V | not publicly available |
| @ 10kΩ | 1.83V | -348V | 28.0V | not publicly available |
| Max output current | (+/-15%) | (+/-20%) | (+/-10%) | 400μA (0.4mA) |
| @ 500Ω | 0.19mA | 363μΑ(0.363 mA) | 37.6mA | not publicly available |
| @2kΩ | 0.18mA | 117μΑ (0.117 mA) | 12.4mA | not publicly available |
| @ 10kΩ | 0.16mA | 38μΑ (0.038 mA) | 2.8mA | not publicly available |
| Duration of primary pulse at 500Ω | Positive: 130µs (0.13msec)Negative: 130µs (0.13msec) | 0.5msec | not publicly available | 60msec |
| Pulse Duration (Cycle) at 500Ω | 265µs (0.265msec) | 1.1msec | 300msec (+phase)124.7msec (-phase, exponential) | 60msec |
| Frequency | 3.80kHz | 15-121Hz | 8Hz fixed | 8.3Hz |
| Net Charge per pulse at 500Ω | 0.025µC | 4µC | 0µC | not publicly available |
| Max phase charge | 0.059µC | 10µC | 11.3µC | not publicly available |
| Max current density at 500Ω | - Standard: 0.15mA/cm²- Scalp: 0.53mA/cm²- Small: | Built-in, Y, Brush: 800μA/cm²(0.80mA /cm²) | 46.4mA/cm² | not publicly available |
| 1.36mA/cm2 | Pencil: | |||
| 19,000μA/cm2(19mA/cm2) | ||||
| With a wet cottonpad (Purified water) | ||||
| - Standard:0.15mA/cm2 | ||||
| - Scalp:0.53mA/cm2Small: 1.36mA/cm2 | ||||
| Max power densityat 500Ω (Smallestelectrode) | 8.51μW/cm2 | Built-in, Y, Brush:Average500μW/cm2 | 2.31mW/cm2(2,310μW/cm2) | not publiclyavailable |
| - With a wetcotton pad11.39μW/cm2 | Pencil: Average3,500μW/cm2 | |||
| Max. AverageCurrent (mA) | 0.105 | not publiclyavailable | not publiclyavailable | not publiclyavailable |
| Burst mode | ||||
| Pulse per burst | N/A | N/A | 160 | 20 |
| Burst per second | N/A | N/A | 1/240 (per electrodegroup) | 8.3 |
| Burst duration | N/A | N/A | 20sec | 2.4 |
| Duty cycle | N/A | N/A | 1/12 | 20.2sec |
| On Time (seconds) | N/A | N/A | 20sec/electrodegroup | not publiclyavailable |
| Off Time (seconds) | N/A | N/A | not publiclyavailable | not publiclyavailable |
| Output Specifications: Mode 2 | ||||
| New Device | Predicate Device | Reference Device | Reference Device | |
| Trade Name | BEAGANK 4TPLUS | EZZI-LIFT Device | Rejuvenique | NuFACE Trinity |
| Indications for Use | The BEAGANK 4TPLUS is a handheldportable device forover-the-counteraesthetic useincluding facial and | The Avazzia OTCTENS for aesthetics,model BEST-AV1TM: EZZI-LIFTTM Device isindicated for over- | Rejuvenique systemis indicated forcosmetic use. | The NuFACETrinity is intendedfor facial and neckstimulation and isindicated for over- |
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| neck stimulation orbody skin stimulation. | the-counter aestheticuse including facialand neck stimulationor body skin stimulation. | the-counter cosmeticuse. | ||
|---|---|---|---|---|
| Waveform Shape | Rectangle, biphasicasymmetric | Positive squarewave followed by adamped sinusoidalwaveform ofvariable durationdepending ondamping and bodyloading | Pulsed biphasic,Rectangular(+phase), Spike (-phase) | Pulsed biphasicmodulated squarewave |
| Max output voltage | (+/-15%) | (+/-20%) | (+/-10%) | 28VDC |
| @ 500Ω | 110mV (0.11V) | -42V | 18.8V | not publiclyavailable |
| @2kΩ | 507mV (0.50V) | -122V | 24.8V | not publiclyavailable |
| @ 10kΩ | 1.87V | -348V | 28.0V | not publiclyavailable |
| Max output current | (+/-15%) | (+/-20%) | (+/-10%) | 400μA (0.4mA) |
| @ 500Ω | 0.45mA | 363μA (0.363mA) | 37.6mA | not publiclyavailable |
| @2kΩ | 0.39mA | 117μA (0.117mA) | 12.4mA | not publiclyavailable |
| @ 10kΩ | 0.24mA | 38μA (0.038mA) | 2.8mA | not publiclyavailable |
| Duration of primarypulse at 500Ω | Positive: 130µs(0.13msec)Negative: 130µs(0.13msec) | 0.5msec | not publiclyavailable | 60msec |
| Pulse Duration(Cycle) at 500Ω | 265µs (0.265msec) | 1.1msec | 300msec (+phase)124.7msec (-phase,exponential) | 60msec |
| Frequency | 3.80kHz | 15-121Hz | 8Hz fixed | 8.3Hz |
| Net Charge per pulseat 500Ω | 0.025μC | 4μC | 0μC | not publiclyavailable |
| Max phase charge | $0.025\mu C$ | $10\mu C$ | $11.3\mu C$ | not publicly available |
| Max current density at 500Ω | Standard:$0.36mA/cm^2$Scalp:$1.25mA/cm^2$Small:$3.21mA/cm^2$ | Built-in, Y, Brush:$800\mu A/cm^2$( $0.8mA/cm^2$ )Pencil:$19,000\mu A/cm^2$( $19mA/cm^2$ ) | $46.4mA/cm^2$ | not publicly available |
| With a wet cotton pad (Purified water) | Standard:$0.10mA/cm^2$Scalp: $0.36 mA/cm^2$Small: $0.92 mA/cm^2$ | |||
| Max power density at 500Ω (Smallest electrode) | $17.46\mu W/cm^2$ | Built-in, Y, Brush:Average $500\mu W/cm^2$ | $2.31mW/cm^2$( $2,310\mu W/cm^2$ ) | not publicly available |
| With a wet cotton pad | $33.87\mu W/cm^2$ | Pencil: Average $3,500\mu W/cm^2$ | ||
| Max. Average Current (mA) | 0.105 | not publicly available | not publicly available | not publicly available |
| Burst mode | ||||
| Pulse per burst | N/A | N/A | 160 | 20 |
| Burst per second | N/A | N/A | 1/240 (per electrode group) | 8.3 |
| Burst duration | N/A | N/A | 20sec | 2.4 |
| Duty cycle | N/A | N/A | 1/12 | 20.2sec |
| On Time (seconds) | N/A | N/A | 20sec/electrode group | not publicly available |
| Off Time (seconds) | N/A | N/A | not publicly available | not publicly available |
| Output Specifications: Mode 3 | ||||
| New Device | Predicate Device | Reference Device | Reference Device |
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| Trade Name | BEAGANK 4TPLUS | EZZI-LIFT Device | Rejuvenique | NuFACE Trinity |
|---|---|---|---|---|
| Indications for Use | The BEAGANK 4TPLUS is a handheldportable device forover-the-counteraestheticuseincluding facial andneck stimulation orbodyskinstimulation. | The Avazzia OTCTENS for aesthetics,model BEST-AV1TM. EZZI-LIFT™ Device isindicated for over-the-counter aestheticuse including facialand neck stimulationor body skinstimulation. | Rejuvenique systemis indicated forcosmetic use. | The NuFACETrinity is intendedfor facial and neckstimulation and isindicated for over-the-counter cosmeticuse. |
| Waveform Shape | Rectangle, biphasicsymmetrical | Positive squarewave followed by adamped sinusoidalwaveform ofvariable durationdepending ondamping and bodyloading | Pulsed biphasic,Rectangular(+phase), Spike (-phase) | Pulsed biphasicmodulated squarewave |
| Max output voltage | (+/-15%) | (+/-20%) | (+/-10%) | 28VDC |
| @ 500Ω | 16.6V | -42 | 18.8V | not publiclyavailable |
| @2kΩ | 21.0V | -122 | 24.8V | not publiclyavailable |
| @10kΩ | 22.5V | -348 | 28.0V | not publiclyavailable |
| Max output current | (+/-15%) | (+/-20%) | (+/-10%) | 400μA |
| @ 500Ω | 30.8mA | 363μA(0.363 mA) | 37.6mA | not publiclyavailable |
| @2kΩ | 8.52mA | 117μA (0.117 mA) | 12.4mA | not publiclyavailable |
| @ 10kΩ | 2.26mA | 38μA (0.038 mA) | 2.8mA | not publiclyavailable |
| Duration of primarypulse at 500Ω | Positive: 80μs(0.08msec)Negative: 80μs(0.08msec) | 0.5msec | not publiclyavailable | 60msec |
| Pulse Duration(Cycle) at 500Ω | 274μs (0.247msec) | 1.1msec | 300msec (+phase)124.7msec (-phase,exponential) | 60msec |
| Frequency | 3.65kHz | 15-121Hz | 8Hz fixed | 8.3Hz |
| Net Charge per pulseat 500Ω | -1.3μC | 4μC | 0μC | not publiclyavailable |
| Max phase charge | 2.2μC | 10μC | 11.3μC | not publiclyavailable |
| Max current densityat 500Ω | - Standard:24.4mA/cm²- Scalp:85.6mA/cm²- Small: 220mA/cm²With a wet cottonpad (Purified water)- Standard:4.26mA/cm²- Scalp:28.21mA/cm²Small:38.43mA/cm² | Built-in, Y, Brush:800μA/cm²(0.8mA/cm²)Pencil:19,000μA/cm²(19mA/cm²) | 46.4mA/cm² | not publiclyavailable |
| Max power densityat 500Ω(Smallestelectrode) | 106638.40μW/cm²With a wetcotton pad1124.0µW/cm² | Built-in, Y, Brush:Average500μW/cm²Pencil: Average3,500μW/cm² | 2.31mW/cm²(2,310µW/cm²) | not publiclyavailable |
| Max. AverageCurrent (mA) | 0 | not publiclyavailable | not publiclyavailable | not publiclyavailable |
| Burst mode | ||||
| Pulse per burst | N/A | N/A | 160 | 20 |
| Burst per second | N/A | N/A | 1/240 (per electrodegroup) | 8.3 |
| Burst duration | N/A | N/A | 20sec | 2.4 |
| Duty cycle | N/A | N/A | 1/12 | 20.2sec |
| On Time (seconds) | N/A | N/A | 20sec/electrodegroup | not publiclyavailable |
| Off Time (seconds) | N/A | N/A | not publiclyavailable | not publiclyavailable |
| Output Specifications: Mode 4 | ||||
| New Device | Predicate Device | Reference Device | Reference Device | |
| Trade Name | BEAGANK 4TPLUS | EZZI-LIFT Device | Rejuvenique | NuFACE Trinity |
| Indications for Use | The BEAGANK 4TPLUS is a handheldportable device forover-the-counteraesthetic useincluding facial andneck stimulation orbody skinstimulation. | The Avazzia OTCTENS for aesthetics,model BEST-AV1TM: EZZI-LIFTTM Device isindicated for over-the-counter aestheticuse including facialand neck stimulationor body skinstimulation. | Rejuvenique systemis indicated forcosmetic use. | The NuFACETrinity is intendedfor facial and neckstimulation and isindicated for over-the-counter cosmeticuse. |
| Waveform Shape | Rectangle,Biphasic symmetric | Positive squarewave followed by adamped sinusoidalwaveform ofvariable durationdepending ondamping and bodyloading | Pulsed biphasic,Rectangular(+phase), Spike (-phase) | Pulsed biphasicmodulated squarewave |
| Max output voltage | (+/-15%) | (+/-20%) | (+/-10%) | 28VDC |
| @ 500Ω | 15.3V | -42V | 18.8V | not publiclyavailable |
| @ 2kΩ | 21.2V | -122V | 24.8V | not publiclyavailable |
| @ 10kΩ | 22.9V | -348V | 28.0V | not publiclyavailable |
| Max output current | (+/-15%) | (+/-20%) | (+/-10%) | 400μA |
| @ 500Ω | 31.4mA | 363μA(0.363 mA) | 37.6mA | not publiclyavailable |
| @ 2kΩ | 8.60mA | 117μA (0.117 mA) | 12.4mA | not publiclyavailable |
| @ 10kΩ | 2.15mA | 38μA (0.038 mA) | 2.8mA | not publiclyavailable |
| Duration of primarypulse at 500Ω | Positive: 92µs(0.092msec)Negative: 92µs(0.092msec) | 0.5msec | not publiclyavailable | 60msec |
| PulseDuration(Cycle) at 500Ω | 610µs (0.61msec) | 1.1msec | 300msec (+phase)124.7msec (-phase,exponential) | 60msec |
| Frequency | 1.64kHz | 15 to 121 Hz | 8 Hz fixed | 8.3Hz |
| Net Charge per pulseat 500Ω | 0µC (biphasicsymmetrical) | 4μC | 0μC | not publiclyavailable |
| Max phase charge | 0.29µC | 10µC | 11.3µC | not publiclyavailable |
| Max current densityat 500Ω | -Standard:25.0mA/cm²Head:87.2mA/cm²Small:224.3mA/cm²With a wet cottonpad (Purified water)-Standard:3.13mA/cm²Scalp:10.97mA/cm²Small:28.21mW/cm² | Built-in, Y, Brush:800μA/cm²(0.8mA/cm²)Pencil: 19,000μA/cm²(19mA/cm²) | 46.4 mA/cm² | not publiclyavailable |
| Max power densityat 500Ω (Smallestelectrode) | -51775.54μW/cm²With a wetcotton pad556.96μW/cm² | Built-in, Y, Brush:Average500μW/cm²Pencil: Average3,500μW/cm² | 2.31mW/cm²(2,310µW/cm²) | not publiclyavailable |
| Max. AverageCurrent (mA) | 0 | not publiclyavailable | not publiclyavailable | not publiclyavailable |
| Burst mode | ||||
| Pulse per burst | N/A | N/A | 160 | 20 |
| Burst per second | N/A | N/A | 1/240 (per electrodegroup) | 8.3 |
| Burst duration | N/A | N/A | 20sec | 2.4 |
| Duty cycle | N/A | N/A | 1/12 | 20.2sec |
| On Time (seconds) | N/A | N/A | 20sec/electrodegroup | not publiclyavailable |
| Off Time (seconds) | N/A | N/A | not publiclyavailable | not publiclyavailable |
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Clinical Test Data: No new clinical studies have been submitted as part of this Premarket Notification.
Tests were performed on the device which demonstrated that the device is safe and Summary of Non-Clinical / effective, performs comparably to and is substantially equivalent to the predicate device. Test Data: Testing confirmed that the device complies with safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1 and 60601-1-2.
Testing confirmed that the device electrodes complies with safety standards for Biocompatibility testing, specifically ISO standards 10993-5, 10993-10, and 10993-23.
Company considers the BEAGANK 4T PLUS device to be substantially equivalent to the Conclusion: predicate device and reference devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
§ 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).