Myolift QT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 27, 2023 Johari Digital Healthcare Limited Pooja Johari Founder and Director Marketing G-582, 584 EPIP, Boranda Jodhpur, Rajasthan 342012 India Re: K213078 Trade/Device Name: Myolift QT Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: March 24, 2023 Received: March 27, 2023 Dear Pooja Johari: 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 aware 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 {1}------------------------------------------------ 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, # Tushar Bansal -S for Heather Dean, PhD Assistant Director 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213078 Device Name Myolift QT Indications for Use (Describe) "Myolift QT" is indicated for facial and neck stimulation and is indicated for over-the-counter cosmetic 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) #### 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." {3}------------------------------------------------ 510(K) SUMMARY {4}------------------------------------------------ # 510 (k) Summary As required by 21 CFR 807.92(c) | Device Name | Myolift QT | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | Submitters name<br>/contact details | Nisha Johari<br>Johari Digital Healthcare Ltd<br>G-582, 584 EPIP, Boranada,<br>Jodhpur - India - 342008<br>Contact number: +1 (818)-521-8947 | | Summary Preparation Date | 06-Jan-23 | | Device Trade Name | Myolift QT | | Classification Name | Transcutaneous Electrical Nerve Stimulator for Pain Relief | | Classification Regulation | 21CFR 882.5890, Class II | | Classification Product Code | NFO | ## Legally marketed Predicate Device | Device Trade Name | ZIIP+ Device | |--------------------------|------------------------------------------------------------| | Classification Name | Transcutaneous electrical nerve stimulator for pain relief | | 510(K) No | K212342 | | Address and Registration | ZIIP, Inc.<br>1910 15th Ave E<br>Seattle, Washington 98112 | | FDA Registration | 3012050654 | {5}------------------------------------------------ #### Device Description The MyoliftQT is a microcurrent, handheld, and mobile application-based device which is easy to operate. The mobile application used in the device supports both types of users (iPhone®/Android™). The user has to download the application via Google Play™ store (Android) /App Store® (IOs) and connect the device via Bluetooth of their phone. The users can thereafter make their profiles accordingly. The purpose of this device is to lift and tone the face and neck. It is a battery-powered device used with conductive gel. The conductive gel is used to reduce the impedance between the electrodes and the skin of the user. Myolift QT has one channel and two output ports. One output is through the applicator ball and the other output is through the lead wire via the USB port connected through the charging port. The Lead wire is connected to the device via USB. And electrodes are connected through the lead wire to give skin treatment to the user. The Metal balls and the electrodes are in contact with the user/patient maximum of 60 min, therefore the Surface-contacting, less than 24hour duration. The Sphere shape applicator balls made up of stainless steel in this device are designed to gently roll over the skin to deliver low-level electrical impulses in the face and neck region. The device delivers current in the range of 350 microamperes and low 160-microampere current. Note: During treatment, only one output port works. In skin treatment, the device minimize the fine lines and wrinkles on the skin. This device delivers two types of waveforms (Erase and Educate) for effective skincare treatment. It is intended to be used by multiple users (multiple applications). The device can be switched ON|OFF by simple touch on the power button. The device offers multiple LED indications (Visual) to indicate the different states of the device. - -A flashing blue LED light indicates that the device is ON|OFF and when the device is connected to Bluetooth, the flashing blue light becomes steady. - -A Red LED indicates battery low while A Green LED indicates the chagrining of the device lt is a portable device having dimensions 6.65″ x 1.49″ [ L X B X H ]. Its outer case is made up of thermoplastic resin. The device comes with a C-type USB cable for the charging of the device. The device is automatically turned off if it is not connected via Bluetooth or not operated for more than 10 minutes. {6}------------------------------------------------ Myolift QT comes with the necessary components. Below is a list of items that are included: | S. No. | Particular | Quantity | |--------|--------------------------------------------------------------------------------|----------| | 1 | User Manual | 1No. | | 2 | Lead Wire with C type connector 1.5 Meter | 1No. | | 3 | Eye mask ( Adhesive Electrodes ) | 1No. | | 4 | Lip mask ( Adhesive Electrodes ) | 1No. | | 5 | Forehead Mask ( Adhesive Electrodes ) | 1No. | | 6 | Conductive Gloves | 1 Pair | | 7 | USB Cable Type C | 1No. | | 8 | Adaptor (Optional) I/p- 100-240V, 0.3A, O/p 5.0V, 2.1A, UL approved ( E317867) | 1No. | #### Indications for Use "Myolift QT" is indicated for facial and neck stimulation and is indicated for over-the-counter cosmetic use. #### Comparison of Technological Characteristics A comparison given below identifies all the changes between the modified and the predicate device: {7}------------------------------------------------ # Basic Device Characteristics – Comparison with Predicate Device | Feature | New Device | Predicate Device | Comparison | |-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------| | Device Name | Myolift QT | ZIIP+ Device | - | | 510 (k) | K213078 | K212342 | - | | OTC/Rx | OTC | OTC | Identical | | Manufactured By | Johari Digital Healthcare<br>Ltd. | ZIIP, LLC | | | Regulation Number | 21CFR, Part 882.5890 | 21CFR, Part 882.5890 | Identical | | Product Code | NFO | NFO | Identical | | Common Name | Transcutaneous<br>Electrical Nerve<br>Stimulator | Transcutaneous<br>Electrical Nerve<br>Stimulator | Identical | | Indications for Use<br>/Intended Use | "Myolift QT" is indicated for<br>facial and neck stimulation<br>and is indicated for over-<br>the-counter cosmetic use. | The ZIIP+ Device is intended<br>for facial and neck stimulation<br>and is indicated for over-the-<br>counter cosmetic use. | Identical | | Mechanism of<br>Action | Microcurrent electrical<br>therapy to deliver skin<br>stimulation through cellular<br>response | Microcurrent electrical<br>therapy to deliver skin<br>stimulation through cellular<br>response | Identical | | Power Source | Internal Rechargeable<br>Lithium-Ion Battery, | Internal Rechargeable<br>Lithium-Ion Battery, | Identical | | Type of Energy | Electrical current | Electrical current | Identical | | Number of Outputs<br>Synchronous or<br>Alternating? | 1+1<br>Alternating | N/A – 1 Output<br>Channel | Identical | | Method of Line<br>Current Isolation | Rechargeable Lithium-ion<br>battery and external<br>charger isolation | One Rechargeable<br>Lithium-Ion Battery,<br>and External Charger<br>Isolation | Identical | | Patient Leakage<br>Current<br>Normal condition<br>Single Fault<br>condition | External Charger<br>Included<br>Normal Condition - 46μΑ<br>Single Fault Condition- 46<br>μΑ | External Charger<br>Included<br>Normal Condition - 46μΑ<br>Single Fault Condition- 46 µA | Identical | | Method of Channel<br>Isolation | N/A - 1 Output<br>Channel | N/A - 1 Output<br>Channel | Identical | | Regulated Current<br>or<br>Regulated Voltage | Both | Both | Identical | | Software/Firmware<br>1<br>Microprocessors<br>Controls? | Yes | Yes | Identical | | Automatic<br>Overload Trip? | Not required because of<br>circuit design (Current and<br>Voltage Limited by Circuit<br>Design and Firmware) | Not required because<br>of circuit design<br>Current and Voltage<br>Limited by Circuit | Identical | | Feature | New Device | Predicate Device | Comparison | | | | Design and Firmware | | | Automatic<br>No-Load Trip? | Yes (Reversion to<br>Fixed Voltage Output) | Yes (Reversion to<br>Fixed Voltage Output) | Identical | | Automatic Shut<br>off? | Yes | Yes | Identical | | Patient Override<br>Control? | Yes | Yes | Identical | | Indicator Display:<br>a) On/Off<br>Status?<br>b) Low<br>Battery?<br>c) Voltage/Current Level? | a) Yes,<br>b) Yes<br>c) Yes LED illumination on<br>target current levels | a) Yes,<br>b) Yes<br>c) Yes LED illumination on<br>target current levels | Identical | | Compliance with<br>Voluntary<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-10<br>ISO 14971 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-1-11 | Identical | | Performance<br>standard | No known required<br>performance standards | No known required<br>performance standards | Identical | | Material/<br>Biocompatibility | Biocompatible materials are<br>typically used in medical<br>devices and are identical to<br>predicate ZIIP+ devices. | Biocompatible materials are<br>typically used in medical<br>devices and are identical to<br>predicate ZIIP devices. | Identical | | Sterility | Not applicable - this device<br>is not sold sterile | Not applicable - this device is<br>ot sold sterile | Identical | | Human Factors | Ergonomic handheld design | Ergonomic handheld design | Identical | | Electrical Safety | Compliant with IEC 606011,<br>60601-1-2, 60601-1-11 | Compliant with IEC 606011,<br>60601-1-2, 60601-1-11 | Identical | | Power Source | Internal Rechargeable<br>Lithium Ion Battery | Internal Rechargeable Lithium<br>Ion Battery | Identical | | Charging Method | External wall adaptor | External wall adaptor | Identical | | Charging Circuitry | Internal to device | Internal to device | Identical | | Special<br>Requirements | Conductive gel | Conductive gel | Identical | | Wireless Capability | Bluetooth Low Energy (BLE) | Bluetooth Low Energy (BLE) | Identical | {8}------------------------------------------------ {9}------------------------------------------------ # Comparison with Output Parameters with Predicate Device ## Mode: Erase | S.<br>NO. | Title | New DEVICE<br>Myolift QT | PREDICATE DEVICE<br>ZIIP Device (K212342) | |-----------|----------------------------------------------------------------------|----------------------------------------------|---------------------------------------------| | | Output Specifications | | | | 1. | Waveform | Symmetrical Biphasic<br>Square wave; | Pulsed Biphasic<br>Modulated Square Wave | | 2. | Shape | Square wave | Square wave | | 3. | Maximum Output<br>Voltage | 175 mV @500Ω<br>684 mV @ 2KΩ<br>3.20V @ 10KΩ | 154mV@ 500Ω<br>465mV@ 2KΩ<br>2.2V @ 10KΩ | | 4. | Maximum Output<br>Current | 350μΑ @ 500Ω<br>342μΑ @ 2ΚΩ<br>320μΑ @ 10ΚΩ | 309μΑ @ 500Ω<br>232μA @ 2ΚΩ<br>202μΑ @ 10ΚΩ | | 5. | Pulse Width | 400000μs | Not publicly available | | 6. | Frequency | 0.625Hz | Not publicly available | | 7. | Beat frequency | NA | NA | | 8. | For multiphasic<br>Waveform<br>Symmetrical Phases?<br>Phase duration | Symmetrical | Not publicly available | | 9. | Net charge | Not Applicable-<br>Battery Operated | Not Applicable- Battery<br>Operated | | 10. | Maximum Phase<br>Charge | 17.5 μC @ 500Ω | 6.16μC @ 500Ω | | 11. | Maximum Current<br>Density | 0.020 mA/cm² @<br>500Ω | 0.034 mA/cm² @ 500Ω | | 12. | Maximum Power<br>Density | 1.50 μW/cm² @<br>500Ω | 3.44 μW/cm² @ 500Ω | | 13 | Additional Features | Mobile Application | Mobile Application | {10}------------------------------------------------ #### Mode: Educate | S.No | Title | New DEVICE | PREDICATE DEVICE | |------|----------------------------------------------------------------------|---------------------------------------------|---------------------------------------------| | | | Myolift QT | ZIIP Device (K212342) | | | Output Specifications | | | | 1. | Waveform | Symmetrical Biphasic<br>Square wave; | Pulsed Biphasic<br>Modulated Square Wave | | 2. | Shape | Square wave | Square wave | | 3. | Maximum Output<br>Voltage | 175 mV @500Ω<br>640 mV @ 2KΩ<br>3.2V @ 10KΩ | 154mV@ 500Ω<br>465mV@ 2KΩ<br>2.2V @ 10KΩ | | 4. | Maximum Output<br>Current | 350mA @ 500Ω<br>320mA @ 2KΩ<br>320mA @ 10KΩ | 309μA @ 500Ω<br>232uA @ 2KΩ<br>202μΑ @ 10KΩ | | 5. | Pulse Width | 600000μs | Not publicly available | | 6. | Frequency | 0.694Hz | Not publicly available | | 7. | Beat frequency | NA | NA | | 8. | For multiphasic<br>Waveform Symmetrical<br>Phases?<br>Phase duration | Symmetrical | Not publicly available | | 9. | Net charge | Not Applicable- Battery<br>Operated | Not Applicable- Battery<br>Operated | | 10. | Maximum Phase<br>Charge | 5.25 μC @ 500Ω | 6.16μC @ 500Ω | | 11. | Maximum Current<br>density | 0.020 mA/cm² @ 500Ω | 0.034 mA/cm² @ 500Ω | | 12. | Maximum Power<br>Density | 1.50 μW/cm² @ 500Ω | 3.44 W/cm² @ 500Ω | | 13 | Additional Features | Mobile Application | Mobile Application | In comparison to the predicate device, there is no change or difference in the indications for use, fundamental scientific principles, performance specifications, or operation of the device. The minor differences in the construction of the devices do not raise any questions regarding the safety and effectiveness of the new device (MYOLIFT QT). The electrical values are within the limits as per the "Guidance Document for Powered Muscle Stimulator 510(k)s", issued on June 9, 1999, ANSI/AAMI NS4:2013 (R2017) standard for electrical stimulators. The fundamental scientific technology is not changed in the new device, and the changes are solely considered for ease of use to the clinician. The Myolift QT generates the same stimulation for the face and neck for cosmetic purposes. While designing the Myolift QT, complete care and considerable measures have been taken to retain its safety and effectiveness. {11}------------------------------------------------ #### Non-clinical Testing The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the predicate device. The Myolift QT device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared device. No new safety or performance issues were raised during testing. Non-clinical Bench Testing: - Reliability Testing - Compliance Testing (IEC60601-1, IEC60601-1-2, IEC60601-1-11) ● - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) - Quality System Regulation (21CFR820) - Application of usability engineering to medical devices (IEC 62366) - Application of risk management to medical devices (ISO 14971) - Symbols to be used with medical device labels, labelling and information to be supplied (ISO 15233) - Biological evaluation of medical devices (ISO 10993-1) - 47 CFR Part 15 FCC requirements of the Equipment Authorization - RF Device #### CONCLUSION The Myolift QT is substantially equivalent to the legally marketed ZIIP+ device (K212342). The Myolift QT device has similar output characteristics, principles of operation, and treatment method, and it has a identical indication for use as the predicate ZIIP+ device. In addition, the Myolift QT device has substantially equivalent technological characteristics and principles as operation, including Bluetooth Low Energy (BLE) capability. We believe that this pre-market submission demonstrates substantial equivalence (SE) to a legally marketed predicate device (ZIIP+ Device, K212342).