SonicLift (Model: ST261) is a non-invasive facial toning device intended for at-home cosmetic use. It has two treatment modes - Vibration Mode and Micro-current Mode. In the Vibration Mode, mechanical vibration at the frequency of 108.7Hz can help to relax facial muscles. In the Micro-current Mode, the low voltage micro-current impulses are emitted from dual probes that are designed for optimal contact with faces of all shapes and sizes. SonicLift, Model: ST261 allows you to adjust the current output from 0 to 280 microamps for a personalized comfort level.

AI/ML Overview

This document is a 510(k) premarket notification for the Pretika SonicLift, Model ST261. It aims to demonstrate substantial equivalence to predicate devices (NuFace and WAHL FRESH FACE) for facial stimulation and cosmetic use. The document focuses on demonstrating safety and performance through bench testing and comparison to existing standards, rather than a clinical study with specific performance metrics against an established ground truth that would be associated with typical diagnostic AI/ML device submissions.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a physical device (facial stimulator) rather than a diagnostic AI/ML algorithm, the "acceptance criteria" are primarily related to safety and electrical performance standards, and comparison to predicate devices, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC. The "device performance" likewise refers to compliance with these standards and physical characteristics.

Acceptance Criteria / Test	Specific Criteria	Reported Device Performance / Result
Biocompatibility
Cytotoxicity Test	Non-toxic ("no more than Grade 2" according to United States Pharmacopoeia for limited skin contacting)	No toxicity to L929 cell. Passed.
Skin Sensitization Test	"Grade 0" according to United States Pharmacopoeia for limited skin contacting	Grade 0. Passed.
Skin Irritation Test	"0-0.4 for Irritation Index" according to United States Pharmacopoeia for limited skin contacting	0 for Irritation Index. Passed.
Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-2-10 standards.	Comply with IEC 60601-1 and IEC 60601-2-10. Passed.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 standard.	Comply with IEC 60601-1-2. Passed.
Software Verification & Validation	Compliance with FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices".	Software verification and validation test conducted.
Waveform Test	Verify the output parameters of the device (Frequency, Max Output Voltage, Max Output Current, Net Charge, Pulse Width, Pulse Duration, etc.) in comparison to predicate devices and relevant FDA guidance. The detailed specific values are numerous, but the general criteria is that the differences "will not raise any safety or effectiveness issue" and comply with IEC 60601-2-10 and FDA guidance.	Conducted and verified. Complies with standards.
Intended Use	Matching the intended use of predicate devices: facial stimulation for over-the-counter cosmetic use.	"SE" (Substantially Equivalent) to predicate devices.
Technological Characteristics	Substantial equivalence to predicate devices in design, functional features, specifications, and materials, particularly regarding electrical and output parameters. Differences should not raise new safety or effectiveness issues.	Various characteristics are compared, with notes explaining substantial equivalence despite minor differences (e.g., power source, number of modes, waveform).

2. Sample Size Used for the Test Set and Data Provenance

This submission is for a physical device and relies on bench testing and comparison to predicate devices, not an AI/ML algorithm that operates on a "test set" of patient data. Therefore, the concept of a "test set" with a sample size and data provenance in the context of an AI/ML device is not applicable here.

The biocompatibility tests (Cytotoxicity, Sensitization, Irritation) would have involved specific biological samples (e.g., L929 cells, guinea pigs) as per ISO standards. However, the exact sample sizes for these biological tests are not provided in this summary.
The electrical safety, EMC, software, and waveform tests are engineering bench tests, not involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. This device is not a diagnostic AI/ML device where "ground truth" for patient data would be established by medical experts for a test set. The "ground truth" for this device's safety and performance is based on compliance with established engineering and biocompatibility standards (IEC, ISO, USP) and comparison to predicate devices, which are defined by regulatory frameworks rather than expert consensus on specific cases.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" of patient data requiring adjudication in the context of an AI/ML diagnostic device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not a diagnostic AI/ML device. MRMC studies are typically used to evaluate the performance of diagnostic devices (often imaging-based AI) compared to human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

The "ground truth," in the context of this device's submission, is compliance with recognized international standards for medical device safety and performance (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-5, ISO 10993-10), and the demonstrated substantial equivalence to legally marketed predicate devices (NuFace, WAHL FRESH FACE). This is a regulatory "ground truth" rather than a clinical "ground truth" of disease presence/absence.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25, 2015

Pretika Corporation Thomas Nichols President 12215 Holly Street Riverside, California 92509

Re: K150077

Trade/Device Name: SonicLift, Model ST261 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO, IRO Dated: January 4, 2015 Received: February 19, 2015

Dear Thomas Nichols:

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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena - S//

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150077

Device Name SonicLift, Model: ST261

Indications for Use (Describe)

This device is intended for facial 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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Sponsor: Pretika Corporation Subject Device: SonicLift, Model: ST261 510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement File No.:

Chapter 6. 510(k) Summary

Date of the summary prepared: November 24, 2015

510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

� 510(k) Owner's Name: Pretika Corporation
� Establishment registration number: Applying
Address: 12215 Holly Street, Riverside, CA 92509 USA �
� Phone: 949-481-8818
Fax: 949-481-8828 �
Contact Person (including title): Thomas Nichols (president) �
E-mail: thomasnichols@pretika.com �

2. Subject Device Information

� Trade Name: SonicLift, Model: ST261
Facial Toning Device Common Name: �
Transcutaneous Electrical Nerve Stimulator for Aesthetic � Classification name:
Purposes
Neurology, Physical Medicine � Review Panel:
nfo, Iro Product Code: �
2 � Regulation Class:
882.5890, 890.5975 Regulation Number: �

3. Predicate Device Information

Sponsor	Carol Cole Company	WAHL CLIPPER CORP
Device Name	NuFace	WAHL FRESH FACE
510(k) Number	K072260	K944909
Product Code	NFO	IRO
RegulationNumber	882.5890	890.5975

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Sponsor: Pretika Corporation Subject Device: SonicLift, Model: ST261 510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement File No.:

Regulation Class	2	1
------------------	---	---

4. Device Description

The SonicLift (Model: ST261) is not for use on injured or otherwise impaired skin or muscles, and in any therapy for the treatment, or prevention of any disease. This device is not for use near any devices with Electromagnetic Interference (EMI), such as cell phones, MRI, CT, RFID etc. or MR environment. This device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper.

The conductive gel used along with the SonicLift, Model: ST261 is the K983964 Batch #6060 Conductive Gel (Skylark Device CO. LTD).

5. Intended Use / Indications for Use

The device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

6. Materials

There are four user directly contracting components in the subject device as the following list.

Component ofDevice RequiringBiocompatibility	Material ofComponent	Body ContactCategory(ISO 10993-1)	Contact Duration(ISO 10993-1)
Housing	ABS plastic	Surface-contactingdevice: skin	Maximum 2 hours(< 24hours)
Output contacts	Stainless steel	Surface-contactingdevice: skin	Maximum 2 hours(< 24hours)
Side edge and button	Mixing silicone	Surface-contactingdevice: skin	Maximum 2 hours(< 24hours)
Conductive gel	Aqua (water),propylene glycol,carbomer,Triethanolamine,phenoxyethanol.	Surface-contactingdevice: skin	Maximum 2 hours(< 24hours)

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Sponsor:	Pretika Corporation
Subject Device:	SonicLift, Model: ST261
File No.:	510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement

The subject device SonicLift, Model: ST261 contacts with the body is surface, skin contact with transient contact duration (less than 24 hours). According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable biological effect is:

Cytotoxicity Sensitization Irritation or intracutaneous reactivity

Therefore, the following biological evaluation tests were conducted to demonstrate the safety of the direct user contacting elements in the subject SonicLift. The tests were conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58). Please refer to Attachment 5 for detail.

Cytotoxicity Test

(1) Test Method

MTT Method in ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity, Edition 3.0, 2009;

(2)Passing Criteria

As our subject device is only for limited skin contacting, we set the criteria for NON-TOXIC to be "no more than Grade 2" according to United States Pharmacopoeia.

(3) Test Result

The Cytotoxicity test result showed the device had no toxicity to L929 cell. The test result is passed the criteria.

Skin Sensitization Test

(1) Test Method

Guinea Pig Maximization Test in ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Edition 3.0, 2010;

(2)Passing Criteria

As our subject device is for limited skin contacting, we set the criteria to be "Grade 0" according to United States Pharmacopoeia.

(3) Test Result

The Skin Sensitization test result for device is Grade 0. The test result is passed the criteria.

Skin Irritation Test

(1) Test Method

0.9% Sodium Chlorid Injection and Sesame oil Extract in ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Edition 3.0, 2010;

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Sponsor:	Pretika Corporation
Subject Device:	SonicLift, Model: ST261
File No.:	510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement

(2)Passing Criteria

As our subject device is for limited skin contacting, we set the criteria to be "0-0.4 for Irritation Index" according to United States Pharmacopoeia.

(3) Test Result

The Skin Irritation test results for Component is 0 for Irritation Index. The test result is passed the criteria.

7. Physical characteristics

Basic Unit Characteristics
Power Source	3.7V li-battery
Method of Line Current Isolation	Type BF Applied Part
Patient leakage current	Comply with IEC 60601-1 and IEC 60601-2-10
- Normal Condition	--
- Single Fault Condition	--
Average DC current through electrodes when device is on but no pulses are being applied	0A
Number of channels	1
Number of modes	2
Output Intensity Level	4
Regulated Current or Regulated Voltage?	Current Control
Software/Firmware/Microprocessor Control?	Yes
Automatic Overload Trip?	No
Automatic No-Load Trip?	No
Automatic Shut Off?	No
User Override Control?	Yes
Indicator	Indicates on/off status, low battery, LED of mode information, intensity level information.
Time Range (minutes)	No
Compliance with Voluntary Standards	YesComply with IEC 60601-1 and IEC 60601-2-10, IEC 60601-1-2
Compliance* with 21 CFR 898	Yes
Main Unit Weight	248g
Accessories Weight	Charge station: 200g; Charger Adapter: 180g
Main Unit Dimension	3.7" L x 7.6" W x 2.8" D
Charger lead wire length	1.6m
Housing Materials of main unit	Housing made from ABS plastic and output contacts made from stainless steel.
Accessories Materials	Plastic

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Sponsor: Pretika Corporation Subject Device: SonicLift, Model: ST261 File No.: 510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement

Vibration Mode Specification
Frequency	108.7 Hz
Micro-Current Mode Specification
Waveform and Shape	Pulsed, symmetric biphasic, rectangular
Maximum Output Voltage (+/- 10%)	156mV @ 500Ω0.78V @ 2kΩ2.6V @ 10kΩ
Maximum Output Current (+/- 10%)	0.31mA @ 500Ω0.39mA @ 2kΩ0.26mA @ 10kΩ
Net Charge (per pulse)	0 mC @500Ω
Phase Charge	21μC @ 500Ω
Maximum Current Density	0.0194mA/cm²@500Ω (The Electrode Size: 16cm²)
Maximum Power Density	3μW/cm² @500Ω(The Electrode Size:16cm²)
Pulse Width	56 ms
Pulse Duration	112 ms
Frequency	8.93 Hz
Contraction and Relaxation Time	Due to different modes. (See below "Program Specification Table")
Additional Features
Environment for operation	Temperature: 5 ~ 40°CHumidity: ≤ 80% RH
Environment for storage	Temperature: 0 ~ 45°CHumidity: ≤ 93% RH

8. Test Summary

SonicLift, Model: ST261 has been evaluated the safety and performance by lab bench testing as following:

Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards �
� Electromagnetic compatibility test according to IEC 60601-1-2 standard
� Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
� The waveform test report has also been conducted to verify the output parameters of the device.

9. Comparison to predicate device and conclusion

The SonicLift (Model: ST261) shares the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate devices, the Nuface (Model: NU-4003) and the WAHL FRESH FACE.

As the SonicLift has a main function of facial stimulation and an auxiliary function of vibration, the classification product code is NFO while the subsequent product code is IRO (510(k)-exempt). Thereof, the facial simulator Nuface (Model: NU-4003) is regarded as the main predicate device. Besides, we select the facial vibrator WAHL FRESH FACE as an auxiliary predicate device.

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In addition, a review of the predicate devices demonstrates that the SonicLift (Model: ST261) is safe and effective as the predicate devices as they share equivalent technological characteristics, features, specifications and materials, and are used to perform the same indicated use. Therefore the proposed device is substantially equivalent (SE) to the predicate devices.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness

Elements ofComparison	Subject Device	Predicate Device	Remark
Device Name andModel	SonicLift, Model: ST261	Nuface, Model: NU-4003WAHL FRESH FACE	--
510(k) Number	Applying	K072260 K944909	--
Manufacturer	Pretika Corporation	Carol Cole CompanyWAHL CLIPPER CORP.	--
Intended Use	This device is intendedfor facial stimulation andis indicated for over-the-counter cosmetic use.	The NuFace FacialToning Device is intendedfor facial stimulation andis indicated for over-the-counter cosmetic use.	The Wahl Fresh Faceis intended for facialstimulation and isindicated for over-the-counter cosmetic use.	SE
Basic Unit Characteristics
Power Source(s)	3.7V li-battery	9V AAA batteries	--SENote 1
Method of LineCurrent Isolation	Type BF Applied Part	Type BF Applied Part	Type BF Applied PartSE
PatientLeakageCurrent	NCSFC	Comply with IEC 60601-1 and IEC 60601-2-10	--SENote 1
Average DCcurrent throughelectrodes whendevice is on butno pulses arebeing applied	0A	--	--SENote 1
Number of OutputChannels	One channel	One channel	One channelSE
Number of OutputModes	2 modes	1 mode	--SENote 1
Elements ofComparison	Subject Device	Predicate Device	Remark
Output IntensityLevel	4 steps	2 steps	SENote 1
Synchronous orAlternating?	N/A	Alternating	SE
Method ofChannel Isolation	N/A	Voltage Isolation	SE
Regulated Currentor RegulatedVoltage?	Current Control	Current Control	SE
Software/Firmware/MicroprocessorControl?	Yes	Yes	SE
AutomaticOverload Trip	No	No	SE
Automatic No-Load Trip	No	No	SE
Automatic ShutOff	No	No	SE
Patient OverrideControl	Yes	Yes	SE
IndicatorDisplay	On/OffStatus	Yes	Yes	SE
	LowBattery	Yes	No	SENote 1
	Voltage/CurrentLevel	Yes	No	SENote 1
Timer Range	No	No	SE
LCD Display	No	Indicate the followinginformation: on/off status,low battery	SENote 1
Compliance withVoluntaryStandards	YesComply with IEC 60601-1 and IEC 60601-2-10,IEC 60601-1-2	YesComply with IEC 60601-1and IEC 60601-2-10, IEC60601-1-2	SE
Compliance* with	Yes	Yes	SE
Elements ofComparison	Subject Device	Predicate Device	Remark
21 CFR 898
Weight	Main unit: 248gCharge station: 200gCharger Adapter: 180g	816g	SENote 2
Dimensions	3.7" L x 7.6" W x 2.8" D	177.8 x 63.5 x 25.4 mm(7" L x 2.5" W x 1" D)	SENote 2
Electrode Size	16 cm²	--	SENote 2
Housing Materialsand Construction	ABS plastic	ABS plastic	SE
Output Specifications
Waveform	Pulsed Biphasic	Pulsed Monophasic	SENote 3
Shape	Rectangular	Rectangular	SE
Maximum OutputVoltage(+/- 10%)	156mV @ 500Ω0.78V @ 2kΩ2.6V@10KΩ	0.158V@ 500Ω0.78V@ 2KΩ2.6V@ 10KΩ	SENote 3
Maximum OutputCurrent(+/- 10%)	0.31mA @ 500Ω0.39mA @ 2kΩ0.26mA @ 10kΩ	0.223mA@ 500Ω0.358mA@ 2KΩ0.263mA@10KΩ	SENote 3
Pulse Duration	112 ms	112 ms	SE
Pulse Frequency	8.93Hz	8.93Hz	SE
Net Charge (perpulse)	0mC @ 500Ω	0.0062µC @ 500Ω	SENote 3
MaximumAverage Current	0.198mA @500Ω	--	SENote 3
Maximum CurrentDensity(r.m.s )	0.0194mA/cm²@500Ω(The Electrode Size:16cm²)	0.341 mA/cm²@500Ω	SENote 3
MaximumAverage PowerDensity	3µW/cm²@500Ω(TheElectrode Size:16cm²)	3.02µW/cm²@500Ω	SENote 3
Contraction andRelaxation Time	Adjustable, due todifferent modes. (Seebelow "ProgramSpecification Table")	Adjustable, due to differentmodes.	SE
Elements ofComparison	Subject Device	Predicate Device	Remark
Additional Features
Environment foroperating	Temperature: 5 ~ 40°CHumidity: ≤ 80% RH	Temperature: 5 ~ 40° CHumidity: 20 ~ 65% RH	SENote 1
Environment forstorage	Temperature: 0 ~ 45°CHumidity: ≤ 93% RH	Temperature: 0 ~40°CHumidity: 10 ~90%RH	SENote 1
Standards
Biocompatibility	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements.	All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.	SE
Electrical Safety	Comply with IEC 60601-1 and IEC 60601-2-10	Comply with IEC 60601-1 and IEC 60601-2-10	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE

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Pretika Corporation Sponsor: Subject Device: SonicLift, Model: ST261 510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement File No.:

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Pretika Corporation Sponsor: Subject Device: SonicLift, Model: ST261 510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement File No.:

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Sponsor: Pretika Corporation Subject Device: SonicLift, Model: ST261 File No.: 510(k) submission report (V1.0), Chapter 7 Truthful and Accuracy Statement

Comparison in Detail(s):

Note 1:

Some of the basic unit characteristics, such as "Power Source(s)", " Weight", " Dimensions", "Operating Environment", "Storage Environment", "Number of Output Intensity Level" and "Indicator Display of Voltage/ Current Level" are a little different from the predicate devices. However, it will not affect the main function and the intended use of the device as they all also comply with IEC 60601-1 requirements. Bisides, the subtle changes of the physical characteristics will not affect the critical functions or the normal use.So the differences will not raise any safety or effectiveness issue.

Note 2:

Although some of the simulation characteristics, such as " Maximum Output Voltage(+/- 10%)", "Maximum Output Current(+/- 10%)", "Pulse Duration", "Pulse Frequency" and "Net Charge (per pulse)" of subject device are different from the simulator predicate device Nuface, they are all proved by waveform report and performance report. And they comply with IEC 60601-2-10 requirements, FDA guidance requirement for Transcutaneous Electrical Nerve Stimulator for Pain Relief and FDA guidance requirement for Powered Muscle Stimulator for Muscle Conditioning. So the differences of the physics specifications will not raise any safety or effectiveness issue.

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Note 3:

Although the "Maximum Output Voltage", "Maximum Output Current", "Net Charge (per pulse)", "Maximum Average Current", "Maximum Current Density", "Maximum Average Power Density" of subject device are a little different from the predicate devices, they all comply with IEC 60601-1, IEC 60601-2-10 requirement, FDA guidance requirement for Transcutaneous Electrical Nerve Stimulator for Pain Relief and FDA guidance requirement for Powered Muscle Stimulator for Muscle Conditioning. So the differences of function specification will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject device "SonicLift, Model: ST261" is Substantial Equivalence to all predicate devices.

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).