(117 days)
Not Found
No
The summary describes a system controlled by software based on user preprogramming and treatment settings, without mentioning any AI/ML capabilities or data-driven learning.
Yes
The device is described as treating "selected medical conditions" and providing therapeutic effects such as "temporary relief of minor muscle aches and pain," "relaxation of muscle spasms," and "symptomatic relief and management of chronic, intractable pain" using RF, EMS, and TENS technology. These are all therapeutic applications.
No
The device description and intended use focus on treatment delivering RF or EMS-TENS technology for various medical conditions, muscle relief, and pain management. It does not mention any function for identifying, analyzing, or determining the nature of a medical condition.
No
The device description explicitly lists hardware components such as an LCD display, power supply, real-time controller, RF generators, and fans, and states the system operates while connected to the T3 Applicator. While software controls the system, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Evolve System with the T3 Applicator uses RF and EMS/TENS technology applied externally to the body for therapeutic purposes (pain relief, muscle stimulation, etc.). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes treatment of medical conditions through external application of energy, not diagnostic testing of biological samples.
- Device Description: The description focuses on the hardware and how it delivers energy, not on components for sample handling or analysis.
Therefore, the Evolve System with the T3 Applicator falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions.
The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The T3 Applicator in EMS mode is intended for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post surgical stimulation of calf muscles to prevent venous thrombosis
The T3 Applicator in TENS mode is intended for:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially.
Product codes (comma separated list FDA assigned to the subject device)
PBX, GZJ, IPF
Device Description
The Evolve System with the T3 Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-Cleared Evolve System platform (a.k.a EmBody System and the subject of K183450). The same platform system was recently FDA-Cleared for the use with the Tone Applicator (subject of K201285).
The Evolve System supports the placement of the following components:
- LCD display touch screen,
- Audio loudspeaker,
- 48V AC/DC power supply,
- Real time controller, distributor card and 2 RF generators,
- Fans
The System operates while connected to the T3 Applicator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body parts requiring treatment as specified in the indication for use
Indicated Patient Age Range
Adult Population which requires treatment as specified in the indication for use
Intended User / Care Setting
Hospital or Clinic setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to demonstrate that the EVOLVE System with the T:3 Applicator performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements.
The following tests were conducted:
- Accuracy testing of the RF output parameters .
- Accuracy of electrode temperature sensors measurements
- Temperature build-up profile measurements .
- Ex-vivo Tissue thermal profile
- Safety and thermal profile testing
- Testing of EMS/TENs output specifications .
The bench testing results demonstrated that the device performs as expected under anticipated conditions of use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
July 19, 2021
InMode Ltd. % Amit Goren Regulatory Consultant A. Stein - Regulatory Affairs Consulting Ltd. 18 Hata'as Str., Suite 21 Kfar Saba, 4442518 Israel
Re: K210877 Trade/Device Name: Evolve System with the T3 Applicator Regulation Numbers: 21 CFR 878.4400 21 CFR 882.5890 21 CFR 890.5850 Regulation Name: Electrosurgical cutting and coagulation device and accessories, Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator Regulatory Class: Class II Product Code: PBX, GZJ, IPF Dated: June 22, 2021 Received: June 24, 2021
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/ofdocs/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.
1
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 (OS) 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/cdrl-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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known)
K210877
Device Name
Evolve System with the T3 Applicator
Indications for Use (Describe)
The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions.
The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The T3 Applicator in EMS mode is intended for:
- Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- · Maintaining or increasing range of motion
- · Immediate post surgical stimulation of calf muscles to prevent venous thrombosis
The T3 Applicator in TENS mode is intended for:
- · Symptomatic relief and management of chronic, intractable pain
- · Post-surgical acute pain
- · Post-trauma acute pain
The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially.
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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3
510(K) SUMMARY
THE EVOLVE SYSTEM WITH THE T3 APPLICATOR
510(k) Number K210877
Applicant Name:
| Company Name: | InMode Ltd. |
|---|---|
| Address: | Tabor Building, Shaar Yokneam |
| Yokneam 2069200 | |
| 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 Ltd |
| Address: | 18 Hata'as St. |
| Kfar Saba 4442518 Israel | |
| Tel: | + 972-9-7670002 |
| Fax: | +972-9-7668534 |
| E-mail: | amit@asteinrac.com |
| Date Prepared: | July 18, 2021 |
| Trade Name: | EVOLVE System with the T3 Applicator |
| Classification Name: | CFR Classification section 890.5850; |
| (Product codes: IPF) | |
| CFR Classification section 882.5890; | |
| (Product codes: GZJ) | |
| CFR Classification section 878.4400; | |
| (Product codes: ISA) | |
| CFR Classification section 878.4400; | |
| (Product codes: PBX) | |
| Classification: | Class II Medical Device |
4
Predicate Devices:
The EVOLVE System with the T3 Applicator is substantially equivalent to the following primary and secondary predicate devices.
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Primary Predicate | ||
| Evolve System with the Tone | ||
| Applicator | InMode Ltd. | K201285 |
| Secondary Predicate | ||
| The EVOLVE System | InMode Ltd. | K183450 |
Device Description:
The Evolve System with the T3 Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-Cleared Evolve System platform (a.k.a EmBody System and the subject of K183450). The same platform system was recently FDA-Cleared for the use with the Tone Applicator (subject of K201285).
The Evolve System supports the placement of the following components:
- LCD display touch screen,
- Audio loudspeaker, ●
- 48V AC/DC power supply,
- Real time controller, distributor card and 2 RF generators,
- Fans
The System operates while connected to the T3 Applicator.
5
| Main Line Frequency (nominal): | 50-60 Hz |
|---|---|
| Input Voltage (nominal): | 100-240 VAC |
| Input Current (rms) | 4A |
| Dimension: | |
| Console [W x H x D] | 46cm W x 46cm D x 100cm H [18.2" W x 18.2" D x 44" H] |
| Applicator [L x D] | T3 Applicator |
| 8.9cm L x 4cm D [3.6" L x 1.6" D] | |
| Weight Console: | 33 Kg (73 lbs.) |
| Tone Applicator Weight: | 0.16 Kg [0.4 lbs.] |
| EMS/TENS | |
| Platform modules | Converts AC input voltage (100-240Vac) to |
| AC/DC power supply | 6Vdc |
| Waveform | Symmetrical Biphasic |
| Shape | Rectangular |
| Intensity (output Voltage) | Up to 50 intensity level (=54 Vpeak) |
| Pulse Width | 20 to 400 $\mu$ Sec |
| T3 Applicator Frequency | 3 to 200 Hz |
| RF | |
| Maximal Output power | 75W |
| Frequency | 1 MHz |
| Pulse duration | 2 sec |
Following are the EVOLVE System with the T3 Applicator specifications:
Intended Use/Indication for Use:
The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions.
The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The T3 Applicator in EMS mode is intended for:
- Relaxation of muscle spasms
- . Prevention or retardation of disuse atrophy
- o Increasing local blood circulation
- . Muscle re-education
6
- Maintaining or increasing range of motion ●
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
The T3 Applicator in TENS mode is intended for:
- Symptomatic relief and management of chronic, intractable pain
- Post-surgical acute pain
- Post-trauma acute pain
The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially.
Performance Standards:
The EVOLVE System with the T3 Applicator has been tested and complies with the following FDA recognized consensus standards:
[Rec. Number 19-4] ANSI AAMI ES 60601-1:2005/(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
- [Rec. Number 19-8] IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- [Rec. Number 17-16] IEC 60601-2-10 Edition 2.1 2016-04 Medical Electrical Equipment - Part 2-10: Particular Requirements for The Basic Safety and Essential Performance of Nerve and Muscle Stimulators
- [Rec. Number 5-89] IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- [Rec. Number 6-389] IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential per
7
Sterilization/Disinfection/Cleaning:
The cleaning and reprocessing instructions set forth in the device user manual for all of the reprocessed device Applicator components. The handle should be thoroughly cleaned by the user by using 70% alcohol absorbed pad for at least 30 sec. The user should carefully examine the applicator components prior to their assembly and usage for complete drying and for any visible damage.
The device user manual and device labels, provide users with the proper symbolling and instructions/warnings for safe and effective device use and for a safe discard of the single use components upon their usage.
All device materials in contact with the patient are biocompatible.
Non-Clinical (Bench) Performance Data:
Bench testing was conducted to demonstrate that the EVOLVE System with the T:3 Applicator performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements.
The following tests were conducted:
- Accuracy testing of the RF output parameters .
- . Accuracy of electrode temperature sensors measurements
- Temperature build-up profile measurements .
- Ex-vivo Tissue thermal profile ●
- Safety and thermal profile testing
- Testing of EMS/TENs output specifications ●
The bench testing results demonstrated that the device performs as expected under anticipated conditions of use.
8
Pre-Clinical (Animal) Performance Data:
Non-Applicable.
Clinical Performance Data:
Non-Applicable.
Substantial Equivalence:
The below table summarizes the main comparison aspects between the EVOLVE System with the T3 Applicator and the proposed predicate devices.
| Characteristic | Subject Device
EVOLVE System
with the T3
Applicator | Primary Predicate
Device
EVOLVE System
with the Tone
Applicator
K201285 | Secondary
Predicate Device
EVOLVE System
with the Tite
Applicator
K183450 |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | InMode Ltd. | InMode Ltd. | InMode Ltd. |
| Prescription/
OTC | Prescription | idem | idem |
| Class
Product Code | Class II
IPF GZJ
ISA PBX | Class II
IPF GZJ | Class II
ISA PBX |
| Indications for
Use | The EVOLVE System
with T3 Applicator
when used in RF
mode is intended for
the temporary relief
of minor muscle
aches and pain,
temporary relief of
muscle spasm, and
temporary
improvement of local
blood circulation.
The EVOLVE System
with T3 Applicator
when used in EMS-
TENS mode is
intended for
EMS mode:
Relaxation of
muscle spasms | The EVOLVE System
with Tone Applicator
is used in EMS mode
for:
Relaxation of
muscle spasms Prevention or
retardation of
disuse atrophy Increasing local
blood circulation Muscle re-
education Maintaining or
increasing range
of motion Immediate
postsurgical
stimulation of
calf muscles to
prevent venous
thrombosis | The InMode EmBody
System with its
designated hand
pieces is intended for
the treatment of the
following medical
conditions;
The
EmBodyPLUS
S hand piece
is intended
for the
temporary
relief of
minor muscle
aches and
pain,
temporary
relief of
muscle
spasm, and
temporary
improvement |
| Characteristic | Subject Device
EVOLVE System
with the T3
Applicator | Primary Predicate
Device
EVOLVE System
with the Tone
Applicator
K201285 | Secondary
Predicate Device
EVOLVE System
with the Tite
Applicator
K183450 |
| | Prevention or
retardation of
disuse atrophy Increasing local
blood
circulation Muscle re-
education Maintaining or
increasing
range of motion Immediate
postsurgical
stimulation of
calf muscles to
prevent venous
thrombosis TENS mode: Symptomatic
relief and
management of
chronic,
intractable pain Post-surgical
and post-
trauma acute
pain The RF treatment
mode and
EMS/TENS mode | In TENS mode it is
used for: Symptomatic
relief and
management of
chronic,
intractable pain Post-surgical and
post-trauma
acute pain | of local blood
circulation. |
| | should not be used
in combination or
sequentially. | | |
| Target
Population | Adult Population
which requires
treatment as
specified in the
indication for use | Idem | Idem |
| Anatomical
Sites | Body parts requiring
treatment as
specified in the
indication for use | Idem | Idem |
| Environment
Used | Hospital or Clinic
setting | Idem | Idem |
| Characteristic | Subject Device
EVOLVE System
with the T3
Applicator | Primary Predicate
Device
EVOLVE System
with the Tone
Applicator
K201285 | Secondary
Predicate Device
EVOLVE System
with the Tite
Applicator
K183450 |
| Applied energy
Design: | RF/EMS-TENS
The EVOLVE
System with T3
Applicator consists
of an AC/DC power
supply unit,
controller, 2 RF
generators and user
interface including
an LCD touch
screen. The delivery
of the RF/electrical
energy is controlled
by a Start/Stop
button positioned on
the front panel.
The System supports
the following
components:
LCD display
touch screenAudio
loudspeaker48V AC/DC
power supplyController2 RF Generators
The System operates
while connected to
the T3 Applicator in
RF mode or in
EMS/TENs mode. | EMS-TENS
The EVOLVE System
with Tone Applicator
consists of an AC/DC
power supply unit,
controller, 2 RF
Generators (disabled)
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 supports
the following
components:
LCD display
touch screenAudio
loudspeaker48V AC/DC
power supplyController2 RF Generators
(disabled)
The System operates
while connected to
the Tone Applicator. | RF
The EVOLVE System
with Tite Applicator
consists of an AC/DC
power supply unit,
controller, 2 RF
generators and user
interface including an
LCD touch screen.
The delivery of the RF
energy is controlled
by a Start/Stop
button positioned on
the front panel.
The System supports
the following
components:
LCD display
touch screenAudio
loudspeaker48V AC/DC
power supplyController2 RF Generators
The System operates
while connected to
the Tite Applicator. |
| - Components
Console | The EVOLVE
System consists of
the following
components:
Console,
including a power
supply unit,
controller and
user interface
including an LCD
touch screen. | The EVOLVE System
consists of the
following
components:
Console, including
a power supply
unit, controller
and user interface
including an LCD
touch screen. | The EVOLVE System
consists of the
following
components:
Console, including
a power supply
unit, controller
and user interface
including an LCD
touch screen. |
| Characteristic | Subject Device
EVOLVE System
with the T3
Applicator | Primary Predicate
Device
EVOLVE System
with the Tone
Applicator
K201285 | Secondary
Predicate Device
EVOLVE System
with the Tite
Applicator
K183450 |
| | 2 RF Generators T3 Applicator with up to 6 units connected to the console via 6 designated cables and 6 designated connection ports. | 2 RF Generators (disabled) Tone applicator with up to 4 units connected to the console via 4 designated cables and 4 designated connection ports. | Tite applicator with up to 8 units connected to the console via 8 designated cables and 8 designated connection ports. |
| Dimension
Console
[W x H x D] | 46cm W x 46cm D x
100cm H [18.2" W x
18.2" D x 44" H] | 46cm W x 46cm D x
100cm H [18.2" W x
18.2" D x 44" H] | 46cm W x 46cm D x
100cm H [18.2" W x
18.2" D x 44" H] |
| Applicator unit
[L x D] | T3 Applicator unit:
67.3mm L x 54.3mm
D [2.7" L x2.2" D] | Tone Applicator unit:
120mm L x 100mm D
[4.8" L x4.0" D] | Tite Applicator unit:
40.9mm L x 36.1mm
D [1.6" L x1.4" D] |
| Cable length | 280 cm [110L] | 280 cm [110L] | 280 cm [110``L] |
| Weight Console | 33.0 Kg [73 lbs.] | 33.0 Kg [73 lbs.] | 33.0 Kg [73 lbs.] |
| Weight applicator | T3: 0.16 Kg [0.4 lbs.] | Tone: 0.22 Kg [0.5 lbs.] | Tite: 0.17 Kg [0.4 lbs.] |
| Applicator unit
treatment area
(EMS/TENS) | T3: 6.46 cm²
(3 small electrodes
$1.05x2.05x3=6.46$ ) | Tone: 12 cm² | |
| Applicator unit
treatment area
(RF) | T3: 33.7 cm² | | Tite: 14.8 cm² |
| Performance Specifications: | | | |
| System | | | |
| Power Source(s) | Main Line
Frequency
(nominal)
50-60Hz
Input Voltage
(nominal)
100-240VAC
Input Current (rms)
4A | Main Line Frequency
(nominal)
50-60Hz
Input Voltage
(nominal)
100-240VAC
Input Current (rms)
4A | Main Line Frequency
(nominal)
50-60Hz
Input Voltage
(nominal)
100-240VAC
Input Current (rms)
4A |
| RF Frequency | 1 MHz | Disabled | 1 MHz |
| Maximal RF
output power | 75 W | Disabled | 50 W |
| Method of Line
Current Isolation | Independent
transformer isolated | Independent
transformer isolated | N/A |
| Characteristic | Subject Device
EVOLVE System
with the T3
Applicator | Primary Predicate
Device
EVOLVE System
with the Tone
Applicator
K201285 | Secondary
Predicate Device
EVOLVE System
with the Tite
Applicator
K183450 |
| Electrical Type | Type BF | Type BF | N/A |
| Patient Leakage
Current - Normal
Condition ( $µ$ A) |