SonicLift

K150077 · Pretika Corporation · NFO · Nov 25, 2015 · Neurology

Device Facts

• Record ID: K150077
• Device Name: SonicLift
• Applicant: Pretika Corporation
• Product Code: NFO · Neurology
• Decision Date: Nov 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2

Indications for Use

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

Device Story

SonicLift (Model ST261) is a non-invasive, at-home facial toning device. It features two modes: Vibration Mode (108.7Hz mechanical vibration for muscle relaxation) and Micro-current Mode (low-voltage micro-current impulses). The device uses dual probes to deliver current (0-280 microamps) to facial muscles. Operated by the user, it requires conductive gel for optimal contact. The device is powered by a 3.7V Li-battery. Output parameters are controlled via an integrated microprocessor. The user adjusts intensity levels to their comfort. The device provides cosmetic facial stimulation; it is not for medical treatment or disease prevention. It must not be used near EMI sources (e.g., cell phones, MRI). Benefits include potential facial muscle relaxation and toning.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance verified through electrical safety testing (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), waveform analysis, and biocompatibility testing (ISO 10993-5 cytotoxicity, ISO 10993-10 sensitization and irritation).

Technological Characteristics

Non-invasive facial stimulator; ABS plastic housing, stainless steel contacts, silicone buttons. Powered by 3.7V Li-battery. Microprocessor-controlled output. Modes: Vibration (108.7 Hz) and Micro-current (pulsed, symmetric biphasic, rectangular waveform; 8.93 Hz frequency). Type BF applied part. Connectivity: Standalone. Biocompatibility per ISO 10993-1. Compliance: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2.

Indications for Use

Indicated for over-the-counter cosmetic facial stimulation in adults.

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

• NuFace (K072260)
• WAHL FRESH FACE (K944909)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of three human profiles facing right, with flowing lines above and below them. The profiles are silhouetted in black, and the overall design is simple and recognizable.

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

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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)

# 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 [e-mail]

"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}------------------------------------------------

#### 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: [phone]
- Fax: [phone] �
- Contact Person (including title): Thomas Nichols (president) �
- E-mail: [e-mail] �

# 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 |
| Regulation<br>Number | 882.5890 | 890.5975 |

{4}------------------------------------------------

#### 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

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.

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 of<br>Device Requiring<br>Biocompatibility | Material of<br>Component | Body Contact<br>Category<br>(ISO 10993-1) | Contact Duration<br>(ISO 10993-1) |
|------------------------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------------|
| Housing | ABS plastic | Surface-contacting<br>device: skin | Maximum 2 hours<br>(< 24hours) |
| Output contacts | Stainless steel | Surface-contacting<br>device: skin | Maximum 2 hours<br>(< 24hours) |
| Side edge and button | Mixing silicone | Surface-contacting<br>device: skin | Maximum 2 hours<br>(< 24hours) |
| Conductive gel | Aqua (water),<br>propylene glycol,<br>carbomer,<br>Triethanolamine,<br>phenoxyethanol. | Surface-contacting<br>device: skin | Maximum 2 hours<br>(< 24hours) |

{5}------------------------------------------------

| 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.

1. 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.

2. 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.

3. 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;

{6}------------------------------------------------

| 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 | Yes<br>Comply 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 |

{7}------------------------------------------------

#### 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 @ 500Ω<br>0.78V @ 2kΩ<br>2.6V @ 10kΩ |
| Maximum Output Current (+/- 10%) | 0.31mA @ 500Ω<br>0.39mA @ 2kΩ<br>0.26mA @ 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°C<br>Humidity: ≤ 80% RH |
| Environment for storage | Temperature: 0 ~ 45°C<br>Humidity: ≤ 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.

{8}------------------------------------------------

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 of<br>Comparison | Subject Device | Predicate Device | Remark | |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name and<br>Model | SonicLift, Model: ST261 | Nuface, Model: NU-4003<br>WAHL FRESH FACE | -- | |
| 510(k) Number | Applying | K072260<br>K944909 | -- | |
| Manufacturer | Pretika Corporation | Carol Cole Company<br>WAHL CLIPPER CORP. | -- | |
| Intended Use | This device is intended<br>for facial stimulation and<br>is indicated for over-the-<br>counter cosmetic use. | The NuFace Facial<br>Toning Device is intended<br>for facial stimulation and<br>is indicated for over-the-<br>counter cosmetic use. | The Wahl Fresh Face<br>is intended for facial<br>stimulation and is<br>indicated for over-the-<br>counter cosmetic use. | SE |
| <b>Basic Unit Characteristics</b> | | | | |
| Power Source(s) | 3.7V li-battery | 9V AAA batteries | --<br>SE<br>Note 1 | |
| Method of Line<br>Current Isolation | Type BF Applied Part | Type BF Applied Part | Type BF Applied Part<br>SE | |
| Patient<br>Leakage<br>Current | NC<br>SFC | Comply with IEC 60601-<br>1 and IEC 60601-2-10 | --<br>SE<br>Note 1 | |
| Average DC<br>current through<br>electrodes when<br>device is on but<br>no pulses are<br>being applied | 0A | -- | --<br>SE<br>Note 1 | |
| Number of Output<br>Channels | One channel | One channel | One channel<br>SE | |
| Number of Output<br>Modes | 2 modes | 1 mode | --<br>SE<br>Note 1 | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
| Output Intensity<br>Level | 4 steps | 2 steps | SE<br>Note 1 | |
| Synchronous or<br>Alternating? | N/A | Alternating | SE | |
| Method of<br>Channel Isolation | N/A | Voltage Isolation | SE | |
| Regulated Current<br>or Regulated<br>Voltage? | Current Control | Current Control | SE | |
| Software/Firmwar<br>e/Microprocessor<br>Control? | Yes | Yes | SE | |
| Automatic<br>Overload Trip | No | No | SE | |
| Automatic No-<br>Load Trip | No | No | SE | |
| Automatic Shut<br>Off | No | No | SE | |
| Patient Override<br>Control | Yes | Yes | SE | |
| Indicator<br>Display | On/Off<br>Status | Yes | Yes | SE |
| | Low<br>Battery | Yes | No | SE<br>Note 1 |
| | Voltage/<br>Current<br>Level | Yes | No | SE<br>Note 1 |
| Timer Range | No | No | SE | |
| LCD Display | No | Indicate the following<br>information: on/off status,<br>low battery | SE<br>Note 1 | |
| Compliance with<br>Voluntary<br>Standards | Yes<br>Comply with IEC 60601-<br>1 and IEC 60601-2-10,<br>IEC 60601-1-2 | Yes<br>Comply with IEC 60601-1<br>and IEC 60601-2-10, IEC<br>60601-1-2 | SE | |
| Compliance* with | Yes | Yes | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
| 21 CFR 898 | | | | |
| Weight | Main unit: 248g<br>Charge station: 200g<br>Charger Adapter: 180g | 816g | SE<br>Note 2 | |
| Dimensions | 3.7" L x 7.6" W x 2.8" D | 177.8 x 63.5 x 25.4 mm<br>(7" L x 2.5" W x 1" D) | SE<br>Note 2 | |
| Electrode Size | 16 cm² | -- | SE<br>Note 2 | |
| Housing Materials<br>and Construction | ABS plastic | ABS plastic | SE | |
| Output Specifications | | | | |
| Waveform | Pulsed Biphasic | Pulsed Monophasic | SE<br>Note 3 | |
| Shape | Rectangular | Rectangular | SE | |
| Maximum Output<br>Voltage(+/- 10%) | 156mV @ 500Ω<br>0.78V @ 2kΩ<br>2.6V@10KΩ | 0.158V@ 500Ω<br>0.78V@ 2KΩ<br>2.6V@ 10KΩ | SE<br>Note 3 | |
| Maximum Output<br>Current(+/- 10%) | 0.31mA @ 500Ω<br>0.39mA @ 2kΩ<br>0.26mA @ 10kΩ | 0.223mA@ 500Ω<br>0.358mA@ 2KΩ<br>0.263mA@10KΩ | SE<br>Note 3 | |
| Pulse Duration | 112 ms | 112 ms | SE | |
| Pulse Frequency | 8.93Hz | 8.93Hz | SE | |
| Net Charge (per<br>pulse) | 0mC @ 500Ω | 0.0062µC @ 500Ω | SE<br>Note 3 | |
| Maximum<br>Average Current | 0.198mA @500Ω | -- | SE<br>Note 3 | |
| Maximum Current<br>Density<br>(r.m.s ) | 0.0194mA/cm²@500Ω<br>(The Electrode Size:<br>16cm²) | 0.341 mA/cm²@500Ω | SE<br>Note 3 | |
| Maximum<br>Average Power<br>Density | 3µW/cm²@500Ω(The<br>Electrode Size:16cm²) | 3.02µW/cm²@500Ω | SE<br>Note 3 | |
| Contraction and<br>Relaxation Time | Adjustable, due to<br>different modes. (See<br>below "Program<br>Specification Table") | Adjustable, due to different<br>modes. | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
| Additional Features | | | | |
| Environment for<br>operating | Temperature: 5 ~ 40°C<br>Humidity: ≤ 80% RH | Temperature: 5 ~ 40° C<br>Humidity: 20 ~ 65% RH | SE<br>Note 1 | |
| Environment for<br>storage | Temperature: 0 ~ 45°C<br>Humidity: ≤ 93% RH | Temperature: 0 ~40°C<br>Humidity: 10 ~90%RH | SE<br>Note 1 | |
| Standards | | | | |
| Biocompatibility | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | SE | |
| Electrical Safety | Comply with IEC 60601-<br>1 and IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 | SE | |
| EMC | Comply with IEC 60601-<br>1-2 | Comply with IEC 60601-1-2 | SE | |

{9}------------------------------------------------

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

{10}------------------------------------------------

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

{11}------------------------------------------------

#### 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.

{12}------------------------------------------------

# 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.