Who is the manufacturer of Beagank 4T Plus?

Belega, Inc. filed the 510(k) submission for Beagank 4T Plus (K233010).

What is the FDA product code for Beagank 4T Plus?

NFO. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Beagank 4T Plus?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Beagank 4T Plus?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Beagank 4T Plus

K233010 · Belega, Inc. · NFO · Nov 21, 2023 · Neurology

Device Facts

Record ID	K233010
Device Name	Beagank 4T Plus
Applicant	Belega, Inc.
Product Code	NFO · Neurology
Decision Date	Nov 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.

Device Story

Handheld portable aesthetic device; uses rechargeable lithium-ion battery; features four metal electrode pads on head. Operates by delivering transcutaneous electrical nerve stimulation (TENS) to face, neck, and body skin. Requires conductive media (wet cotton pad with purified water or cosmetic liquid) for pulse generation. Includes scalp and small attachments. User-operated for cosmetic purposes. Output consists of four selectable operational modes with varying electrical pulse parameters. Healthcare providers do not interact with output; device is for consumer self-use. Benefits include aesthetic skin stimulation.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via electrical safety, electromagnetic compatibility, and biocompatibility testing.

Technological Characteristics

Handheld aesthetic TENS device; ABS plastic housing; internal rechargeable lithium-ion battery; Type BF patient leakage isolation. Four metal electrode pads. Connectivity: standalone. Sterilization: non-sterile. Electrical safety: IEC 60601-1, IEC 60601-1-2. Biocompatibility: ISO 10993-5, 10993-10, 10993-23.

Indications for Use

Indicated for over-the-counter aesthetic use including facial, neck, and body skin stimulation for general users.

Regulatory Classification

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.

Predicate Devices

Avazzia OTC TENS for Aesthetics, model BEST-AV1: EZZI LIFT Device (K191951)

Reference Devices

Rejuvenique® system, Model RJV-10 (K011935)
NuFACE Trinity (K181008)

Related Devices

K252553 — Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) · Shenzhen Jianchao Intelligent Technology Co., Ltd. · Oct 9, 2025
K250227 — JOVS Electric Stimulation Beauty Device (JE2) · Shenzhen Qianyu Technology Co., Ltd. · Oct 17, 2025
K191951 — Avazzia OTC TENS for aesthetics, model BEST-AV1: EZZI-LIFT Device · Avazzia, Inc. · Apr 27, 2021
K102494 — THE BUZZ FACIAL TONING SYSTEM · Daka International , Ltd. · Dec 9, 2011
K190269 — PureLift · Xtreem Pulse, LLC · Aug 28, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {3}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) SUMMARY | Owner/Submitter: | Belega Co., Ltd. 1-4-20 Sonezaki Shinchi, Kita-ku Osaka-shi, Osaka, Japan 530-0002 | |-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Ken Block Consulting Co., Ltd. Ms. Nana Nagashita Regulatory consultant 1-9-9 Tsukiji, Chuo-ku Tokyo, Japan 104-0045 TEL: +81-3-6260-6688 FAX: +81-3-6260-6689 nagashita@kenblockconsulting.com | | Date Prepared: | September 20, 2023 | | Submission Type: | Traditional 510(k) | | Proposed Device | Manufacturer: BELEGA Co., Ltd. Trade Name: BEAGANK 4T PLUS Common Name: Aesthetic TENS Device Classification Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Product Code: NFO Regulatory Standard: 21 CFR 882.5890 | | Predicate Device: | 510(k) Number: K191951 Manufacturer: Avazzia, Inc. Trade Name: Avazzia OTC TENS for Aesthetics, model BEST-AV1: EZZI LIFT Device Common Name: Aesthetic TENS Device Classification Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Product Code: NFO Regulatory Standard: 21 CFR 882.5890 | | Reference Device: | 510(k) Number: K011935 Manufacturer: Salton Inc. Trade Name: Rejuvenique® system, Model RJV-10 Common Name: Aesthetic TENS Device Classification Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Product Code: NFO, GYB (Media, Conductive) Regulatory Standard: 21 CFR 882.5890, 21 CFR 882.1275 (Media, Conductive) | | Reference Device: | 510(k) Number: K181008 Manufacturer: Carol Cole Company dba NuFACE Trade Name: NuFACE Trinity Common Name: Aesthetic TENS Device Classification Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Product Code: NFO | {5}------------------------------------------------ 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 4T PLUS | EZZI-LIFT Device | Rejuvenique | NuFACE Trinity | | | 510(k) | K233010 | K191951 | K011935 | K181008 | | | Indication for Use | 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 Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device is indicated for over-the- counter aesthetic use including facial and neck stimulation or body skin stimulation. | Rejuvenique system is indicated for cosmetic use. | The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over- the-counter cosmetic use. | | | Device Class | Class II | Class II | Class II | Class II | | | Operating Power | Internal rechargeable Lithium-ion battery | Two 1.5 V AA batteries | 9 V battery | Internal rechargeable Lithium-ion battery | | | Method of Line Current Isolation | Type BF | Unknown | Unknown | Type BF | | | Patient Leakage Current | Normal | DC: <1μΑ AC: <1μΑ Tested per IEC 60601-1 | Unknown | Unknown | N/A - Battery operated | | | Single fault | DC: <1μΑ AC: <1μΑ Tested per IEC 60601-1 | Unknown | Unknown | N/A - Battery operated | | Ave. DC current through electrodes when device is on but no pulse are being applied (μΑ) | | <1μΑ | Unknown | Unknown | Unknown | | Output Channels | Method of Channel Isolation | N/A - 1 output channel | Unknown | Electrode group selected by relays | N/A - 1 output channel | | Regulated Current or Regulated Voltage | | Voltage | Unknown | Voltage | Both | | Automatic Overload Trip | | Not required due to circuit design | Unknown | No | Not required due to circuit design | | Automatic No-Load Trip | | Not required due to circuit design | Unknown | No | Yes | | Automatic Shut Off | | Yes | Yes | Yes | Yes | | Patient Override Control | | Yes | Unknown | Yes | Yes | | Weight | | 136g | 153g (5.4 ounces) | 80 g | 9 oz. without charging base | | Number of output modes | | 4 modes: maximum 5 minutes each | 4 modes: 60 minutes | 1 | Unknown | | Low Battery Indicator | | Yes | Yes | Yes | Yes | | Sterility | | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | | Electrical safety | | IEC 60601-1 Medical electrical equipment - Part 1 General requirements for basic safety and essential performance IEC 60601-1-2 Medical electrical | IEC 60601-1 Medical electrical equipment - Part 1 General requirements for safety IEC 60601-1-2 Medical electrical equipment - Part 1-2: General | Unknown | IEC 60601-1 IEC 60601-1-2 | | | Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnet ic disturbances – Requirements and tests | for basic safety and essential performance – Collateral Standard: Electromagnet ic disturbances – Requirements and tests IEC 60601-2- 10 medical electrical equipment – Part 2:10; Particular requirements for the safety of nerve and muscle stimulators | | | | | Housing Materials and Construction | ABS | PCBs inside plastic case housing | ABS Plastic, snap latch assembly | Thermoplastic | | | Accessories | Small and Scalp attachment | Built-in, Y, Brush, Pencil | Unknown | Unknown | | {6}------------------------------------------------ {7}------------------------------------------------ ### Table 2: Technological Characteristics | Output Specifications: Mode 1 | | | | | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | | New Device | Predicate Device | Reference Device | Reference Device | | Trade Name | BEAGANK 4T PLUS | EZZI-LIFT Device | Rejuvenique | NuFACE Trinity | | Indications for Use | 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 Avazzia OTC TENS for aesthetics, model BEST- AV1TM: EZZI- LIFTTM Device is indicated for over- the-counter aesthetic use including facial and neck stimulation or body skin stimulation. | Rejuvenique system is indicated for cosmetic use. | The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over- the-counter cosmetic use. | {8}------------------------------------------------ | 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 cotton pad (Purified water) | | | | | | - Standard:0.15 mA/cm2 | | | | | | - Scalp: 0.53mA/cm2 Small: 1.36mA/cm2 | | | | | Max power density at 500Ω (Smallest electrode) | 8.51μW/cm2 | Built-in, Y, Brush: Average 500μW/cm2 | 2.31mW/cm2 (2,310μW/cm2) | not publicly available | | | - With a wet cotton pad 11.39μW/cm2 | Pencil: Average 3,500μW/cm2 | | | | 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 2 | | | | | | | New Device | Predicate Device | Reference Device | Reference Device | | Trade Name | BEAGANK 4T PLUS | EZZI-LIFT Device | Rejuvenique | NuFACE Trinity | | Indications for Use | The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic use including facial and | The Avazzia OTC TENS for aesthetics, model BEST- AV1TM: EZZI- LIFTTM Device is indicated for over- | Rejuvenique system is indicated for cosmetic use. | The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over- | {9}------------------------------------------------ {10}------------------------------------------------ | | neck stimulation or body skin stimulation. | the-counter aesthetic use including facial and neck stimulation or body skin stimulation. | | the-counter cosmetic use. | |------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------| | 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 | 110mV (0.11V) | -42V | 18.8V | not publicly available | | @2kΩ | 507mV (0.50V) | -122V | 24.8V | not publicly available | | @ 10kΩ | 1.87V | -348V | 28.0V | not publicly available | | Max output current | (+/-15%) | (+/-20%) | (+/-10%) | 400μA (0.4mA) | | @ 500Ω | 0.45mA | 363μA (0.363mA) | 37.6mA | not publicly available | | @2kΩ | 0.39mA | 117μA (0.117mA) | 12.4mA | not publicly available | | @ 10kΩ | 0.24mA | 38μA (0.038mA) | 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 | $0.025\mu C$ | $10\mu C$ | $11.3\mu C$ | 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 | {11}------------------------------------------------ {12}------------------------------------------------ | Trade Name | BEAGANK 4T PLUS | EZZI-LIFT Device | Rejuvenique | NuFACE Trinity | |---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | 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 Avazzia OTC TENS for aesthetics, model BEST- AV1TM. EZZI- LIFT™ Device is indicated for over- the-counter aesthetic use including facial and neck stimulation or body skin stimulation. | Rejuvenique system is indicated for cosmetic use. | The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over- the-counter cosmetic use. | | Waveform Shape | Rectangle, biphasic symmetrical | 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 | 16.6V | -42 | 18.8V | not publicly available | | @2kΩ | 21.0V | -122 | 24.8V | not publicly available | | @10kΩ | 22.5V | -348 | 28.0V | not publicly available | | Max output current | (+/-15%) | (+/-20%) | (+/-10%) | 400μA | | @ 500Ω | 30.8mA | 363μA(0.363 mA) | 37.6mA | not publicly available | | @2kΩ | 8.52mA | 117μA (0.117 mA) | 12.4mA | not publicly available | | @ 10kΩ | 2.26mA | 38μA (0.038 mA) | 2.8mA | not publicly available | | Duration of primary pulse at 500Ω | Positive: 80μs (0.08msec) Negative: 80μs (0.08msec) | 0.5msec | not publicly available | 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…