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.

AI/ML Overview

This document is a 510(k) Summary for the Myolift QT device, which is a Transcutaneous Electrical Nerve Stimulator for cosmetic use. The summary focuses on demonstrating substantial equivalence to a predicate device (ZIIP+ Device, K212342) rather than presenting a performance study with acceptance criteria in the typical sense for an AI/ML medical device.

Therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or not provided in this document. The "acceptance criteria" here are based on meeting various electrical safety, biocompatibility, and quality standards, and demonstrating technological characteristics similar to the predicate device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is primarily assessed through its adherence to various regulatory and safety standards, and by comparing its electrical output parameters to those of the predicate device. The "acceptance criteria" are implied by compliance with these standards and the demonstration of substantial equivalence.

Acceptance Criteria (Implied by Compliance)	Reported Device Performance (Summary of Findings)
Electrical Safety Standards: - IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) - IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests) - IEC 60601-1-11 (Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment) - IEC 60601-2-10 (Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators)	Compliant with IEC 60601-1, 60601-1-2, 60601-1-11. (Specific results like patient leakage current, overload/no-load trip described as within limits based on circuit design).
Quality Management Systems: - ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes) - 21 CFR 820 (Quality System Regulation)	Covered by the manufacturer's quality system.
Risk Management: - ISO 14971 (Medical devices – Application of risk management to medical devices)	Compliant with ISO 14971.
Usability Engineering: - IEC 62366 (Medical devices – Application of usability engineering to medical devices)	Compliant with IEC 62366. Ergonomic handheld design noted.
Biocompatibility: - ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)	Biocompatible materials used, identical to predicate device.
Wireless Capability: - 47 CFR Part 15 FCC requirements of the Equipment Authorization - RF Device	Compliant with 47 CFR Part 15 FCC requirements. Uses Bluetooth Low Energy (BLE).
Functional Equivalence to Predicate Device: - Indications for Use: "facial and neck stimulation and… over-the-counter cosmetic use." - Mechanism of Action: Microcurrent electrical therapy. - Power Source: Internal Rechargeable Lithium-Ion Battery. - Output Parameters (Mode: Erase): - Waveform: Symmetrical Biphasic Square wave - Max Output Voltage: 175 mV @500Ω, 684 mV @ 2KΩ, 3.20V @ 10KΩ - Max Output Current: 350μΑ @ 500Ω, 342μΑ @ 2ΚΩ, 320μΑ @ 10ΚΩ - Max Phase Charge: 17.5 μC @ 500Ω - Output Parameters (Mode: Educate): - Waveform: Symmetrical Biphasic Square wave - Max Output Voltage: 175 mV @500Ω, 640 mV @ 2KΩ, 3.2V @ 10KΩ - Max Output Current: 350mA @ 500Ω, 320mA @ 2KΩ, 320mA @ 10KΩ - Max Phase Charge: 5.25 μC @ 500Ω - Other features: Mobile application, auto shut-off, patient override control, LED indicators.	Identical indications for use. Identical mechanism of action. Identical power source. Output parameters for both "Erase" and "Educate" modes were presented and compared to the predicate device. While specific values differ (e.g., maximum output voltage/current, maximum phase charge), the document concludes these "minor differences… do not raise any questions regarding the safety and effectiveness" and that "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."

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 describes a 510(k) submission for a physical device, not an AI/ML model. Therefore, "test set" and "data provenance" in the context of an AI/ML study are not applicable. The device undergoes "non-clinical bench testing" to demonstrate compliance with standards and equivalence. No patient data is involved in this described testing.

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. This is not an AI/ML device requiring human expert annotation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication for a test set is mentioned.

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 is not an AI/ML device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a standalone physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's safety and effectiveness is established through its compliance with recognized electrical safety standards (IEC 60601 series), biocompatibility standards (ISO 10993-1), and quality management systems (ISO 13485, 21 CFR 820), as well as demonstrated similarity in technological characteristics and intended use to a legally marketed predicate device. There is no "ground truth" derived from patient outcomes or expert consensus for AI model training/testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set with ground truth.

Summary

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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

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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,

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

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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)

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510(K) SUMMARY

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510 (k) Summary As required by 21 CFR 807.92(c)

Device Name	Myolift QT
Submitters name/contact details	Nisha JohariJohari Digital Healthcare LtdG-582, 584 EPIP, Boranada,Jodhpur - India - 342008Contact 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.1910 15th Ave ESeattle, Washington 98112
FDA Registration	3012050654

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Device Description

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.

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

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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:

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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 HealthcareLtd.	ZIIP, LLC
Regulation Number	21CFR, Part 882.5890	21CFR, Part 882.5890	Identical
Product Code	NFO	NFO	Identical
Common Name	TranscutaneousElectrical NerveStimulator	TranscutaneousElectrical NerveStimulator	Identical
Indications for Use/Intended Use	"Myolift QT" is indicated forfacial and neck stimulationand is indicated for over-the-counter cosmetic use.	The ZIIP+ Device is intendedfor facial and neck stimulationand is indicated for over-the-counter cosmetic use.	Identical
Mechanism ofAction	Microcurrent electricaltherapy to deliver skinstimulation through cellularresponse	Microcurrent electricaltherapy to deliver skinstimulation through cellularresponse	Identical
Power Source	Internal RechargeableLithium-Ion Battery,	Internal RechargeableLithium-Ion Battery,	Identical
Type of Energy	Electrical current	Electrical current	Identical
Number of OutputsSynchronous orAlternating?	1+1Alternating	N/A – 1 OutputChannel	Identical
Method of LineCurrent Isolation	Rechargeable Lithium-ionbattery and externalcharger isolation	One RechargeableLithium-Ion Battery,and External ChargerIsolation	Identical
Patient LeakageCurrentNormal conditionSingle Faultcondition	External ChargerIncludedNormal Condition - 46μΑSingle Fault Condition- 46μΑ	External ChargerIncludedNormal Condition - 46μΑSingle Fault Condition- 46 µA	Identical
Method of ChannelIsolation	N/A - 1 OutputChannel	N/A - 1 OutputChannel	Identical
Regulated CurrentorRegulated Voltage	Both	Both	Identical
Software/Firmware1MicroprocessorsControls?	Yes	Yes	Identical
AutomaticOverload Trip?	Not required because ofcircuit design (Current andVoltage Limited by CircuitDesign and Firmware)	Not required becauseof circuit designCurrent and VoltageLimited by Circuit	Identical
Feature	New Device	Predicate Device	Comparison
		Design and Firmware
AutomaticNo-Load Trip?	Yes (Reversion toFixed Voltage Output)	Yes (Reversion toFixed Voltage Output)	Identical
Automatic Shutoff?	Yes	Yes	Identical
Patient OverrideControl?	Yes	Yes	Identical
Indicator Display:a) On/OffStatus?b) LowBattery?c) Voltage/Current Level?	a) Yes,b) Yesc) Yes LED illumination ontarget current levels	a) Yes,b) Yesc) Yes LED illumination ontarget current levels	Identical
Compliance withVoluntaryStandards	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10ISO 14971	IEC 60601-1,IEC 60601-1-2,IEC 60601-1-11	Identical
Performancestandard	No known requiredperformance standards	No known requiredperformance standards	Identical
Material/Biocompatibility	Biocompatible materials aretypically used in medicaldevices and are identical topredicate ZIIP+ devices.	Biocompatible materials aretypically used in medicaldevices and are identical topredicate ZIIP devices.	Identical
Sterility	Not applicable - this deviceis not sold sterile	Not applicable - this device isot sold sterile	Identical
Human Factors	Ergonomic handheld design	Ergonomic handheld design	Identical
Electrical Safety	Compliant with IEC 606011,60601-1-2, 60601-1-11	Compliant with IEC 606011,60601-1-2, 60601-1-11	Identical
Power Source	Internal RechargeableLithium Ion Battery	Internal Rechargeable LithiumIon Battery	Identical
Charging Method	External wall adaptor	External wall adaptor	Identical
Charging Circuitry	Internal to device	Internal to device	Identical
SpecialRequirements	Conductive gel	Conductive gel	Identical
Wireless Capability	Bluetooth Low Energy (BLE)	Bluetooth Low Energy (BLE)	Identical

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Comparison with Output Parameters with Predicate Device

Mode: Erase

S.NO.	Title	New DEVICEMyolift QT	PREDICATE DEVICEZIIP Device (K212342)
	Output Specifications
1.	Waveform	Symmetrical BiphasicSquare wave;	Pulsed BiphasicModulated Square Wave
2.	Shape	Square wave	Square wave
3.	Maximum OutputVoltage	175 mV @500Ω684 mV @ 2KΩ3.20V @ 10KΩ	154mV@ 500Ω465mV@ 2KΩ2.2V @ 10KΩ
4.	Maximum OutputCurrent	350μΑ @ 500Ω342μΑ @ 2ΚΩ320μΑ @ 10ΚΩ	309μΑ @ 500Ω232μA @ 2ΚΩ202μΑ @ 10ΚΩ
5.	Pulse Width	400000μs	Not publicly available
6.	Frequency	0.625Hz	Not publicly available
7.	Beat frequency	NA	NA
8.	For multiphasicWaveformSymmetrical Phases?Phase duration	Symmetrical	Not publicly available
9.	Net charge	Not Applicable-Battery Operated	Not Applicable- BatteryOperated
10.	Maximum PhaseCharge	17.5 μC @ 500Ω	6.16μC @ 500Ω
11.	Maximum CurrentDensity	0.020 mA/cm² @500Ω	0.034 mA/cm² @ 500Ω
12.	Maximum PowerDensity	1.50 μW/cm² @500Ω	3.44 μW/cm² @ 500Ω
13	Additional Features	Mobile Application	Mobile Application

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Mode: Educate

S.No	Title	New DEVICE	PREDICATE DEVICE
		Myolift QT	ZIIP Device (K212342)
	Output Specifications
1.	Waveform	Symmetrical BiphasicSquare wave;	Pulsed BiphasicModulated Square Wave
2.	Shape	Square wave	Square wave
3.	Maximum OutputVoltage	175 mV @500Ω640 mV @ 2KΩ3.2V @ 10KΩ	154mV@ 500Ω465mV@ 2KΩ2.2V @ 10KΩ
4.	Maximum OutputCurrent	350mA @ 500Ω320mA @ 2KΩ320mA @ 10KΩ	309μA @ 500Ω232uA @ 2KΩ202μΑ @ 10KΩ
5.	Pulse Width	600000μs	Not publicly available
6.	Frequency	0.694Hz	Not publicly available
7.	Beat frequency	NA	NA
8.	For multiphasicWaveform SymmetricalPhases?Phase duration	Symmetrical	Not publicly available
9.	Net charge	Not Applicable- BatteryOperated	Not Applicable- BatteryOperated
10.	Maximum PhaseCharge	5.25 μC @ 500Ω	6.16μC @ 500Ω
11.	Maximum Currentdensity	0.020 mA/cm² @ 500Ω	0.034 mA/cm² @ 500Ω
12.	Maximum PowerDensity	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.

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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).

Regulation Number and Section

§ 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).