K Number

Device Name

InMode System with Tone Applicator

Manufacturer

InMode Ltd.

Date Cleared

2019-12-17

(120 days)

Product Code

IPF GZJ

Regulation Number

890.5850

Intended Use

The InMode System with Tone Applicator is used in EMS mode for: Prevention or retardation of disuse atrophy Maintaining or increasing range of motion Muscle re-education Relaxation of muscle spasms Increasing local blood circulation Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis And in TENS mode for: Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain

Device Description

The InMode System in combination with Tone Applicator (manufactured by InMode Ltd.), is a versatile device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications. The InMode System with Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The delivery of the electrical energy is controlled by a Start/Stop button positioned on the front panel.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K132284

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device using standard EMS and TENS technologies with a basic controller and user interface. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.

Therapeutic

Yes
The 'Intended Use / Indications for Use' section clearly lists several medical applications for the device, such as prevention of disuse atrophy, muscle re-education, relaxation of muscle spasms, increasing local blood circulation, and pain relief. These are all therapeutic purposes.

Diagnostic

The provided text only describes the therapeutic uses of the device (EMS and TENS for muscle and pain management) and does not mention any diagnostic capabilities.

SaMD (Software as a Medical Device)

The device description explicitly states that the InMode System with Tone Applicator consists of hardware components including an AC/DC power supply unit, controller, user interface with LCD touch screen, and a Start/Stop button for controlling electrical energy delivery. It also mentions a Tone Applicator which is a physical component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended uses listed are all related to direct physiological effects on the body (muscle stimulation, pain relief, circulation, etc.). IVDs are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening.
Device Description: The description details a system that delivers electrical energy to the body via applicators. This is consistent with a therapeutic device, not a diagnostic one that analyzes samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro diagnostics.

The device is clearly described as a therapeutic device utilizing EMS and TENS technologies for various medical conditions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The InMode System with Tone Applicator is used in EMS mode for:

Prevention or retardation of disuse atrophy
Maintaining or increasing range of motion
Muscle re-education
Relaxation of muscle spasms
Increasing local blood circulation
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

And in TENS mode for: Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain

Product codes

IPF, GZJ

Device Description

The System support the following components:
. LCD display touch screen
. Audio loudspeaker
48V AC/DC power supply .
. Controller
. Fans

The System operates while connected to the Tone Applicator.

Following are The InMode System with Tone Applicator specifications:
Main Line Frequency (nominal): 50-60 Hz
Input Voltage (nominal): 100-240 VAC
Input Current (rms) 2A
Dimension:
Console 35cm W x 35cm D x 100cm H
[W x H x D] [18.2" W x 18.2" D x 40" H]
Applicator Tone Applicator
[L x D] 12cm L x 10cm D [4.7" L x 4" D]
Weight Console: 20 Kg (44 lbs)
Tone Applicator Weight: 0.22 Kg [0.5 lbs.]
Platform modules Converts AC input voltage (90-264Vac) to
AC/DC power supply 48Vdc, 300W
Waveform Symmetrical Biphasic
Shape Rectangular
Intensity (output Voltage) Up to 50 intensity level (=54 Vpeak)
Pulse Width
Tone Applicator 20 to 400 μ S
Frequency
Tone Applicator 3 to 200 Hz

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Bench testing was conducted to demonstrate that the InMode System with Tone Applicator performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements. The device was tested for validation of output waveform, basic unit characteristics, and output specifications.

The bench testing results demonstrated that the device performs as expected under anticipated conditions of use

The biocompatibility of the Tone Applicator outer components (handle and electrodes) was justified using a biocompatibility assessment performed on a family of related products and by scientific evidence. The following biocompatibility tests were performed as part of the biocompatibility assessment:

Test: Cytotoxicity Study Using the ISO Elution Method
Test Summary: The test article extract showed no evidence of causing cell lysis or toxicity
Conclusions: Non-toxic

Test: ISO Acute Systemic Toxicity Study in Mice
Test Summary: The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
Conclusions: Non-toxic

Test: ISO Guinea Pig Maximization Sensitization Test
Test Summary: There was no mortality or evidence of systemic toxicity from the extracts injected into mice
Conclusions: No irritation/sensitization

Non-Clinical (Bench) Performance Data:
Bench testing was conducted to demonstrate that the InMode System with Tone Applicator performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements. The device was tested for validation of output waveform, basic unit characteristics, and output specifications.
The bench testing results demonstrated that the device performs as expected under anticipated conditions of use.

Key Metrics

Not Found

Predicate Device(s)

K132284

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 17, 2019

InMode Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel

Re: K192249

Trade/Device Name: InMode System with Tone Applicator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: September 16, 2019 Received: September 18, 2019

Dear Amit Goren:

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 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Vivek Pinto, Ph.D. 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

Indications for Use

510(k) Number (if known) K192249

Device Name InMode System with Tone Applicator

Indications for Use (Describe)

The InMode System with Tone Applicator is used in EMS mode for:

Prevention or retardation of disuse atrophy

Maintaining or increasing range of motion

Muscle re-education

Relaxation of muscle spasms

Increasing local blood circulation

Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

And in TENS mode for: Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

THE INMODE SYSTEM WITH TONE APPLICATOR

510(k) Number K192249

Applicant Name:

Company Name:	InMode Ltd.
Address:	Tabor Building, Shaar Yokneam
Yokneam 20692
Israel
Tel: +972-4-9097470
Fax: +972-4-9097471
E-mail: amit@asteinrac.com
Contact Person:
Official Correspondent:	Amit Goren
Company Name:	A. Stein - Regulatory Affairs Consulting Lt
Address:	20 Hata'as Str., Suite 102
Kfar Saba 4442520 Israel
Tel: +972-9-7670002
Fax: +972-9-7668534
E-mail: amit@asteinrac.com
Date Prepared:	December 11, 2019
Trade Name:	The InMode System with Tone Applicator
Classification Name:	Powered Muscle Stimulator
Common Name:	Powered Muscle Stimulator
Regulation Number:	890.5850 & 882.5890
Product Code:	IPF & GZJ
Classification:	Class II Medical Device

Predicate Device:

The InMode System with Tone Applicator is substantially equivalent to the following predicate device.

Predicate	Manufacturer	510(k) No.
Vectra Neo Clinical Therapy System	DJO, LLC	K132284

Device Description:

The System support the following components:

. LCD display touch screen
. Audio loudspeaker
48V AC/DC power supply .
. Controller
. Fans

The System operates while connected to the Tone Applicator.

Following are The InMode System with Tone Applicator specifications:

Main Line Frequency (nominal):	50-60 Hz
Input Voltage (nominal):	100-240 VAC
Input Current (rms)	2A
Dimension:
Console	35cm W x 35cm D x 100cm H
[W x H x D]	[18.2" W x 18.2" D x 40" H]
Applicator	Tone Applicator
[L x D]	12cm L x 10cm D [4.7" L x 4" D]
Weight Console:	20 Kg (44 lbs)
Tone Applicator Weight:	0.22 Kg [0.5 lbs.]
Platform modules	Converts AC input voltage (90-264Vac) to
AC/DC power supply	48Vdc, 300W
Waveform	Symmetrical Biphasic
Shape	Rectangular
Intensity (output Voltage)	Up to 50 intensity level (=54 Vpeak)
Pulse Width
Tone Applicator	20 to 400 $ \mu $ S
Frequency
Tone Applicator	3 to 200 Hz

Intended Use/Indication for Use:

The InMode System with Tone Applicator is used in EMS mode for:

트 Prevention or retardation of disuse atrophy
Maintaining or increasing range of motion ■
Muscle re-education ■
Relaxation of muscle spasms
Increasing local blood circulation
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

And in TENS mode for:

Symptomatic relief and management of chronic, intractable pain 트
트 Post-surgical acute pain
Post-traumatic acute pain

Performance Standards:

The InMode System with Tone Applicator has been tested and complies with the following FDA recognized consensus standards:

· IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005 Edition 3rd, MOD)
· Appendix 6-Clause 3.2.2.1 and Clause 3.2.2.2 from ANSI/AAMI NS4:2013/(R)2017
· IEC 60601-1-2: Medical electrical equipment; Part 1-2: Collateral Standard: Electromagnetic compatibility - Requirements and tests, Edition 4.0 (2014). Environment of intended uses: Professional Healthcare Facility Environment
· IEC 60601-2-10 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10 Edition 2.1 2016-04) IEC 60601-2-10: 2012, AMD1:2016 for use in conjunction with IEC 60601-1:2005/AMD1:2016
· IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability (60601-1-6 Edition 3.1 2013-10, AMD1:2013)

Non-Clinical (Bench) Performance Data:

The bench testing results demonstrated that the device performs as expected under anticipated conditions of use

The biocompatibility of the Tone Applicator outer components (handle and electrodes)

was justified using a biocompatibility assessment performed on a family of related products and by scientific evidence. The following biocompatibility tests were performed as part of the biocompatibility assessment:

Test	Test Summary	Conclusions
Cytotoxicity Study Using the ISO
Elution Method	The test article extract
showed no evidence of
causing cell lysis or
toxicity	Non-toxic
ISO Acute Systemic Toxicity
Study in Mice	The test article extracts
showed no evidence of
causing delayed dermal
contact sensitization in the
guinea
pig.	Non-toxic
ISO Guinea Pig Maximization
Sensitization Test	There was no mortality or
evidence of systemic
toxicity from the extracts
injected into mice	No irritation/
sensitization

Pre-Clinical (Animal) Performance Data:

Non-Applicable.

Clinical Performance Data:

Non-Applicable.

Substantial Equivalence:

The below table summarizes the main comparison aspects between the InMode System with Tone Applicators and the proposed predicate device.

Characteristic	Subject Device	Predicate
510(k) file No.	K192249	K132284
Device Name	InMode System with
Tone Applicator	Vectra Neo
Clinical Therapy
System
Manufacturer	InMode Ltd.	DJO, LLC
Class, Product Code.	Class II
IPF GZJ	Class II
IPF, GZJ
IMG, HCC, GZI
Characteristic	Subject Device	Predicate
510(k) file No.	K192249	K132284
Device Name	InMode System with
Tone Applicator	Vectra Neo
Clinical Therapy
System
Manufacturer	InMode Ltd.	DJO, LLC
LIH, ILY
Design:	The InMode System with
Tone Applicator consists
of an AC/DC power
supply unit, controller and
user interface including an
LCD touch screen. The
delivery of the electrical
energy is controlled by a
Start/Stop button
positioned on the front
panel.
The System support the
following components:
• LCD display touch
screen
• Audio loudspeaker
• 48V AC/DC power
supply
• Controller
• Fans
The System operates
while connected to the
Tone Applicator.	The Vectra Neo
Vlinical Therapy
System consists of
an AC/DC power
supply unit,
controller and user
interface including
color display. The
delivery of the
electrical energy is
controlled by a
Start/Stop button
positioned on the
front panel.
Mechanism of Action	Muscle contraction by
electrical pulsing.	Idem
Components
Console	The InMode System
consists of the following
components:
• Console, including a
power supply unit,
controller and user
interface including an
LCD touch screen.
• Tone Applicator
connected to the
console via a cable.	Vectra Neo Clinical
Therapy System
consists of the
following
components:
• Console,
including a power
supply unit,
controller and
user interface
including an LCD
touch screen.
• Several types of
applicators for
different
Characteristic	Subject Device	Predicate
510(k) file No.	K192249	K132284
Device Name	InMode System with
Tone Applicator	Vectra Neo
Clinical Therapy
System
Manufacturer	InMode Ltd.	DJO, LLC
		indications (EMS,
Ultrasound, EMG
& Laser)
connected to the
console via a
cable.
Dimension
Console
[W x H x D]	35cm W x 35cm D
x 100cm H
[18.2" W x 18.2" D x
40" H]	not publicly
available
Applicator
[L x D]	Tone Applicator
12cm L x 10cm D
[4.7" L x 4" D]
Weight Console	20.0 Kg [44 lbs.]	not publicly
available
Weight applicator	Tone: 0.22 Kg [0.5 lbs.]
Performance
Specifications:
Components
Console	Main Line Frequency
(nominal)
50-60Hz
Input Voltage (nominal)
100-240VAC
Input Current (rms)
2A	not publicly
available
Method of Line Current Isolation	Independent transformer
isolated	not publicly
available
Electrical Type	Type BF	not publicly
available
Patient Leakage Current - Normal
Condition (μΑ)