(287 days)
No
The description focuses on the device's electrical stimulation parameters and its similarity to the predicate device, with no mention of AI or ML.
No
The "Intended Use / Indications for Use" states, "The Arasys Genius is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind." and "None of the Arasys Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated." It is specifically designed for "muscle conditioning to stimulate healthy muscles."
No
The device is intended for muscle conditioning to stimulate healthy muscles, not for diagnosing medical conditions. The "Intended Use" explicitly states it is "not intended to be used in conjunction with therapy or treatment of medical conditions of any kind."
No
The device description explicitly states it is a "muscle stimulator with six ports" and mentions hardware characteristics like "output current," "output voltage," and an "LCD display." This indicates it is a physical hardware device, not software only.
Based on the provided text, the Arasys Genius is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Arasys Genius Function: The Arasys Genius is a muscle stimulator that applies electrical impulses to the body's muscles. It works externally on the body, not by analyzing samples taken from the body.
- Intended Use: The intended use is for "muscle conditioning to stimulate healthy muscles," which is a physical application, not a diagnostic one.
- Device Description: The description details electrical stimulation technology and its application to muscles, not the analysis of biological samples.
Therefore, the Arasys Genius falls under the category of a physical therapy or muscle conditioning device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Arasys Genius is intended for muscle conditioning to stimulate healthy muscles. The Arasys Genius is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physician licensed in the state in which he or she practices. The Arasys Genius is intended to be operated by a trained professional who is always present to monitor treatment.
Product codes
NGX
Device Description
The Arasys Genius has the exact same technological characteristics, the same number of channels and the exact same frequencies as the predicate. Arasys Genius is made by UV Innovations by the same engineers and technicians that make the Ion Magnum Genius K12315B. Arasys Genius has the exact same technology of the predicate, Ion Magnum Genius K123158 with the exceptions. The Arasys Genius is a muscle stimulator with six ports just like the predicate and one output that is the same for all ports just like the predicate. The unit is designed for healthy men & women to provide muscle conditioning. Arasys Genius stimulator provides selections of different programs through manual adjustment of the three different frequencies of the device, 90 Hz, 100 Hz, in an identical fashion as the predicate. The Arasys Genius maximum output current is 100 ma which is equivalent to the maximum output current of the predicate. The Arasys has a maximum output voltage of 200 volts which is equivalent to the maximum output voltage of the predicate. An LCD display shows the balance treatment time in the same fashion as it happens with the predicate. The output signal is biphasic, rectangular and based on a voltage and current regulated technology as it does in the predicate. The unit is easy and simple to use. The Arasys has an identical indication for use just like the predicate as it is intended for muscle conditioning to stimulate healthy muscles. The Aras is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physioian licensed in the state in which he or she practices.
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
The Arasys Genius is intended to be operated by a trained professional who is always present to monitor treatment. Both the Arasys Genius and the predicate, the Ion Magnum Genius K123158 are meant to be used in a professional setting like a spa, a medical spa or a professional office and to be operated by a professional and not by the patient.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows a logo with the words "ION GENIUS" below a three-dimensional lattice structure. The lattice is composed of interconnected circles and lines, creating a cube-like framework. The text "ION GENIUS" is stylized with a blocky, outlined font, giving it a modern and technical appearance. The overall design suggests a connection to science, technology, or innovation.
APR 2 8 2014
TRADITIONAL 510 K SUMMARY
1833 Kalakaua Ave, Suite 905 Honolulu, HI 96821 Phone: +1-866-25-YOUNG/808-395-0656 FAX: 877-26-YOUNG/808-395-0787 Email:info@arasysperfector.com Website www.arasysperfector.com
510(k) Summary
Submitter's name:
Address:
lon Genius, Inc.
Corporate Headquarters 1833 Kalakaua Ave Suite #905 Honolulu, HI 96815
Manufacturing Facility UV Innovations Ltd BIC 1 Innova Park Mollison Ave, Enfield, Middlesex, EN3 7XU, UK
Telephone:
FAX:
UK: +442032861886 USA +1 808 395-0656 * +1-866-25-YOUNG +1-808 395 0787
1
| Company E-mail: | quality@iellios.com |
|---|---|
| Contact Person: | research@iellios.com |
| Contact Person Telephone: | 1-808 6461948 |
| Date of Summary | |
| Is re-submitted: | February, 2014 |
| FDA Establishment Registration No: | 3003588228 (Ion Genius Inc) |
| Proprietary Name: | Arasys Genius |
| Common Name: | Muscle Stimulator for Conditioning |
| Regulation Description: | Powered Muscle Stimulator for Muscle Conditioning |
| Panel Code | 89 |
| Product Code: | NGX |
| Submission Type | 510(k) |
| Regulation Number | 890.5850 |
| Device Class | II |
| Trade Name: | ARASYS GENIUS |
| Common Name: | Powered Muscle Stimulator for Muscle Conditioning |
| Classification Name: | Stimulator, muscle, powered, for muscle conditioning |
| Contact Person: | Xanya Sofra Weiss. Ph.D |
| Contact Person e-mail | research@iellios.com |
| Contact Person Telephone: | 1-808 6461948 |
| Date that the Summary was | |
| prepared | July, 2013 |
| Distributed by: | Ion Genius, INC |
| Corporate Headquarters | |
| 1833 Kalakaua #905 | |
| Honolulu, HI 96815 | |
| Tel: 866-25-YOUNG tel:808-395-0656 | |
| Fax: 877-26-YOUNG |
2
1.. Ion Magnum Genius Contact Name: Xanya Sofra-Weiss. Ph.D lon Genius Inc / Ion Magnum LTD Regulation No 890.5850 K 123158 Stimulator, muscle, powered, for muscle conditioning Product Code: NGX
Device Description: The Arasys Genius has the exact same technological characteristics, the same number of channels and the exact same frequencies as the predicate. Arasys Genius is made by UV Innovations by the same engineers and technicians that make the lon Magnum Genius K12315B. Arasys Genius has the exact same technology of the predicate, lon Magnum Genius K123158 with the exceptions. The Arasys Genius is a muscle stimulator with six ports just like the predicate and one output that is the same for all ports just like the predicate. The unit is designed for healthy men & women to provide muscle conditioning. Arasys Genius stimulator provides selections of different programs through manual adjustment of the three different frequencies of the device, 90 Hz, 100 Hz, in an identical fashion as the predicate. The Arasys Genius maximum output current is 100 ma which is equivalent to the maximum output current of the predicate. The Arasys has a maximum output voltage of 200 volts which is equivalent to the maximum output voltage of the predicate. An LCD display shows the balance treatment time in the same fashion as it happens with the predicate. The output signal is biphasic, rectangular and based on a voltage and current regulated technology as it does in the predicate. The unit is easy and simple to use. The Arasys has an identical indication for use just like the predicate as it is intended for muscle conditioning to stimulate healthy muscles. The Aras is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physioian licensed in the state in which he or she practices.
NOTE 1: All channel;s outputs are isolated from each other. They have their own transformers and amplifiers which are independent from neighboring channels or outputs. The only common thing between the outputs is their connectors to the power supply, the start button, the programs button and the pulse button.
There is a transformer that translates energy received from the mains into micro currents. Hence there is an insulation of mains from circuitry. From Circuitry to output there is also insulation through the transformer. Therefore there is a double separation between mains and the human body.
This unit contains 32 self-adhesive electrodes that already have 510K clearance (K970426)
The Arasys Genius power source is 1 1 OV - 240 V AC Mains, 50-60 Hz which are identical to the predicate. The patient leakage current is 0.07 microamps under both the normal and fault conditions which are again are the exact same specs as the predicate. Channels are synchronous and are isolated by separate transformers the way the channels of the predicate are synchronous and isolated by separate
3
Image /page/3/Picture/0 description: The image shows a device labeled "arasys genius" with several knobs and ports. The device has six knobs arranged in two rows, each labeled with "CHANNEL" followed by a number from 1 to 3. Above the knobs are corresponding indicator lights. In the lower right corner of the device is a logo with the letters "ag".
transformers. Arasys Genius has an automatic overload trip, just like the predicate but not an automatic no load trip just like the predicate that does not have a no load trip, therefore in terms of the overload trip features the Arasys Genius and the predicate are identical.. The Arasys Genius is also equivalent to the predicate in that it has an automatic shut off and patient override control for additional safety. Indicator displays include on and off status just like it does in the predicate. Arasys Genius is an IEC Class 1 device and an IEC 60417-5333, type BF applied part device exactly like the predicate.
Proposed Conditions for Use: Both the Arasys Genius and the predicate, the lon Magnum Genius K123158 are meant to be used in a professional setting like a spa, a medical spa or a professional office and to be operated by a professional and not by the patient.
In terms of how the device interacts with other devices. Neither the Arasys Genius nor the predicate the lon Magnum Genius K123158 affect or are affected by other devices that may be in the same spa or office room.
In terms of how the Device interacts with the patient: Both Arasys Genius and Ion Magnum Genius K123158 interact in the same way with the patient. Both devices have cables that are screwed into the device. The other end of each cable has clips covered in plastic that snap into self adhesive pads. The self adhesive pads used both with the Arasys Genius and the predicate have been cleared (K970426) and therefore, they have been independently tested for biocompatibility, electrical performance, adhesive performance, stability, and reuse of such electrodes. These cleared self adhesive pads and they are applied onto the patient's muscles in the same fashion in both the Arasys Genius and the predicate.
The expected life of the device at least 10 to 15 years because inside the machine are microswitches that last for about 50,000 hours. Our company lon Genius Inc offers life warranty on the lon Magnum Genius. This means that we will repair any parts for free for as long as the customer owns the device.
The device enclosure has no protection against water because if the machine is completely closed up it may become overheated which will damage the device. There is a warning to keep the device away from
Image /page/3/Picture/7 description: The image shows a black cable with two white connectors on one end and a silver connector on the other end. The cable is coiled in the background. The two white connectors are different shapes, one is more rectangular and the other is more square. The silver connector has four pins.
liquids and water both on the device and the manual. The Device is for non-continuous operation. The Arasys Genius is identical to the Ion Magnum Genius in that it has 6 3-pin din sockets that are located three on each side of the device THE DEVICE CABLES SCREW INTO THE DEVICE AND REMAIN SCREWED AT ALL TIMES. As seen in the pictures there are no exposed parts in the plastic covered cables so whoever is holding the cable is completely insulated and safe. ALL parts are touchproof The silver part that you see at the 3-pin din ending that goes into the device is plastic, so whoever holds it is completely insulated and safe. There are no exposed parts. Overall, the ARASYS GENIUS just like the lon
Magnum Genius lead wires screw into the device and remain screwed in at all times comply with IEC
4
60601-1:2005 Section 8.5.2.3 where connectors for electrical connections on a patient leads shall be constructed so that the said part cannot become connected to earth or possible hazardous voltage while the patient connection(s) contact the patient.
When the device is turned on, the device are delivered to the patient's body to stimulate and condition the muscles. This procedure is identical in both the Arasys Genius and the predicate.
The Arasys Genius technological characteristics are identical to the predicate
-
- Biphasic Rectangular Waveform
-
- Synchronous channels
-
- Maximum output voltage
-
- Maximum output current
-
- Identical frequencies
-
- Pulse Duration
-
- Pulse width
-
- Maximum Phase Charge
-
- Maximum Current Density
-
- Channels' method of isolation by separate transformers
-
- Identical Electrodes
-
- Similar current leakage
-
- Same accessories
-
- Same electrodes that are cleared K970426
-
- Identical number of channels
-
- Equivalent dimensions, weight and Housing materials and construction
-
- Identical method of line current isolation
-
- Identical net charge
Design and Use of the Device
| Question | Yes | No |
|---|---|---|
| Is the device intended for prescription use (21 CFR 801 Subpart D)? | X | |
| Is the device intended for over-the-counter use (21 CFR 807 Subpart | X | |
| Does the device contain components derived from a tissue or other biologic source? | X | |
| Is the device provided sterile? | X | |
| Is the device intended for single use? | X | |
| Is the device a reprocessed single use device? | X | |
| If yes, does this device type require reprocessed validation data? | ||
| Does the device contain a drug? | X | |
| Does the device contain a biologic? | X | |
| Does the device use software? | X | |
| Does the submission include clinical information? | X | |
| Is the device implanted? | X |
Intended Use
Arasys Genius K 132179 is intended for muscle conditioning to stimulate healthy muscles. The Arasys Genius
5
is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physician licensed in the state in which he or she practices. The Arasys Genius is intended to be operated by a trained professional who is always present to monitor treatment.
COMPARISON OF INDICATIONS FOR USE OF ARASYS GENIUS AND PREDICATE K123158
Arasys Genius K 132179 is intended for muscle conditioning to stimulate healthy muscles. The Arasys Genius is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Arasys Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physician licensed in the state in which he or she practices. The Arasys Genius is intended to be operated by a trained professional who is always present to monitor treatment. The Arasys Genius is intended to be operated by a trained professional who is always present to monitor treatment.
Ion Magnum Geniu K123158 s is intended for muscle conditioning to stimulate healthy muscles. The Ion Magnum Genius is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Ion Magnum Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Ion Magnum Genius is only offered under prescription given by a physician licensed in the state in which he or she practices.
Substantial Equivalence based on the Indicatins of Use Statement: When compared to the predicated device, lon Magnum Genius K123158 the Arasys Genius has the same intended use. Therefore, the Arasys Genius is substantially equivalent to the predicate marketed device lon Magnum Genius K123158
6
COMPARISON OF DEVICE DESCRIPTION, SAFETY AND EFFECTIVENESS OF ARASYS GENIUS TO PREDICATE DEVICES:
| Arasys Genius K132179 is a Muscle stimulator
with six independent channels which electrical
current can be regulated individually
Biphasic rectangular impulses with electrical mean
equal to zero. Maximum output current is 100 mA
and maximum voltage output is 200 volts. The
device gives 50V output at 500 Ohms overload and
200 volts at 10K Ohms overload. Maximum
quantity of electricity per channel:40 µC Impulse
width: 400 to 500 µsecs. The three Arasys Genius
frequencies, 90 Hz, 100 and 120Hz are within the
same range as the predicate. The electrical pulses
generated by the Arasys Genius are transmitted to the
muscles via self-adhesive electrodes, Axelgaard
type electrodes electrodes which are cleared (510K
K970426) The electrodes are identical to those
used by the predicate. | Ion Magnum Genius K123158" (K123158) is
a Muscle stimulator with six independent channels
which electrical current can be regulated individually
Biphasic rectangular impulses with electrical mean equal to
zero. Maximum output current is 100 mA and maximum
voltage output is 200 volts. The device gives 50V output
at 500 Ohms overload and 200 volts at 10K Ohms
overload. Maximum quantity of electricity per channel: 40
µC Impulse width: 400 to 500 µsecs. The three Arasys
Genius frequencies, 90 Hz, 100 and 120Hz are within the
same range as the predicate. The electrical pulses
generated by the Arasys Genius are transmitted to the
muscles via self-adhesive electrodes, Axelgaard type
electrodes electrodes (K970426) |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Other equivalence aspects between Arasys Genius and the Predicate
| Other
equivalence
aspects
between
Arasys Genius
and the
Predicate | 1. Arasys Genius and the predicate devices are identical in terms of the thermal
safety (there is no thermal energy for Arasys Genius or the predicate)
-
The chemical safety is equivalent (since this is applicable to neither the Arasys
Genius nor the predicate) -
Sterility is equivalent (since neither the Arasys Genius nor the predicate require
sterilization or are supplied sterile.) -
The Arasys Genius uses disposable pads that do not need sterilization that are
equivalent to the pads of the predicate which also do not need sterilization
because they are disposable. -
Biocompatibility of the Arasys disposable pads is equivalent to those of the
predicate and it is independently tested because the disposable pads are tested
by the company that provides them and they are cleared (K970426).
Biocompatibility is performed by the company from which these disposable pads
are purchased (Axelgaard). Arasys uses disposable pads item no: SN2020 which
are square 2" x 2" (5cm x 5cm) which have a 510K number K970426 and
comply to ISO10993-5 Biological Evaluation of Medical Devices part 5 Test for in
vitro cytotoxicity & ISO10993-10. The are made by Axelgaard Manufacturing Co.
LtD, 520 Industrial Way Fallbrook California 92028, USA which has a Certificate
of Registration Quality Management System - ISO 13485:2003 and holds
certificate no FM 40363 and operates a Quality Management System which
complies with the requirements of ISO 13485: 2003 for the following scope: The
design and development, manufacture and distribution of hydrogel and non-
invasive electrodes: Effective date 03/11/2012 - Expiry Date:
03/12/2015.). |
|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
7
| 6. The cables carrying the impulses to the pads and the connectors are both
designed to insulate the client and operator from inadvertent contact with the
relatively weak electrical impulses. Should the connectors be dislodged in use, for
instance, by the client changing position during treatment, the insulation will
ensure no direct contact with the skin will take place. The Arasys cables remain
| screwed on and attached to the device as are the cables of the predicate devices. |
|---|
| 7. Proposed Conditions for Use: Both the Arasys Genius and the predicate, the lon |
| Magnum Genius K123158 are meant to be used in a professional setting like a |
| spa, a medical spa or a professional office and to be operated by a professional |
| and not by the patient. |
OUTPUT SPECIFICATIONS COMPARING ARASYS GENIUS WITH THE PREDICATE DEVICES
| | ARASYS GENIUS
K132179 | Ion Magnum Genius
K123158 | Equivalent |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------|
| Waveform | Biphasic | Biphasic | Equivalent |
| Synchronous or
alternating channels | synchronous | synchronous | Equivalent |
| Dimension of Device | 15.5 inches length
4.5 height
7.5 width | 15.5 inches length
8.5 height
7.5 width | Equivalent |
| Weight of the
Device | 8 pounds | 8 pounds | Equivalent |
| Weight of
Accessories | 4.7 pounds | 4.7 pounds | Equivalent |
| Indicator Display | Yes | Yes | Equivalent |
| Low Battery | N/A | N/A | Equivalent |
| Voltage Current
Level | | | |
| Shape | Yes | Yes | Equivalent |
| | Rectangular | Rectangular | Equivalent |
| Max Output Voltage | 50V @ 500 Ω
200 V @10k Ω | 50V @ 500 Ω
200 V @10k Ω | Equivalent |
| Max Output Current | 100 ma at 500
Ohms | 100 ma at 500 Ohms | Equivalent |
| Frequency (Hz)
for Muscle
Conditioning | 90 Hz
100 Hz
120Hz | 90Hz
100 Hz
120Hz | Equivalent |
| | | | |
| Pulse Duration | 416-500 µsec | 416-500 µsec | Equivalent |
| Pulse Width | 416-500 µsec | 416-500 µsec | Equivalent |
| Maximum Phase
Charge | 50 µC @ 500 Ω at
90 and 100 Hz
40 µC @ 500 Ω at
120 Hz | 50 µC @ 500 Ω at 90 and
100 Hz
40 µC @ 500 Ω at 120 Hz | Equivalent |
| Maximum Current
Density (mA/cm2) | 4 mA /cm2 | 4 mA/cm2 | Equivalent |
| Maximum Power
Density (W/Cm2) | 0.0012 W/cm^2 | 0.0012 W/cm^2 | Equivalent |
| Current or Voltage
Driven | Voltage Driven | Current Driven
Voltage | Equivalent |
| Symmetrical
Phases of Waveform | Yes | Yes | Equivalent |
| Regulated
Current/ voltage | Regulated Voltage | Regulated Voltage | Equivalent |
| Number of Channels | 6 | 6 | Equivalent |
| Method of Channel
Isolation | Channels are
isolated by
separated
transformers | Channels are isolated by
separated transformers | Equivalent |
| Self Adhesive
Electrodes Axelgaard
Type K 970426 | identical | Identical. | Equivalent |
| Cables that screw into
the device | identical | identical. | Equivalent |
| Current Leakage | 0.07 μΑ | 0.07 μΑ | Equivalent |
| Net Charge | 10,000
microcoulombs at
500 Ohms
4,000
microcoulombs at
2K Ohms
2,500
microcoulombs at
10K Ohms | 10,000 microcoulombs at
500 Ohms
4,000 microcoulombs at 2K
Ohms
2,500 microcoulombs at
10K Ohms | Equivalent |
| Method of Line Current
Isolation | Separate
Transformers. | Separate Transformers | Equivalent |
| Housing Material and
Construction | Metal Enclosure | Metal Enclosure | Equivalent |
29
.
8
،
·
י
、
·
9
. . . . . .
10
Image /page/10/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure embracing a globe or sphere. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2014
Ion Genius, Inc. Xanya Sofra-Weiss, Ph.D. Director of Research and Training 1833 Kalakaua Ave, Suite #905 Honolulu, HI 96821
Re: K132179
Trade/Device Name: Arasys Genius Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: March 17, 2014 Received: March 27, 2014
Dear Dr. Xanya Sofra-Weiss:
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
11
Page 2 - Dr. Xanya Sofra-Weiss
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor YowIndustry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carlos L. Peña -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
12
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132179
Device Name Arasys Genius
Indications for Use (Describe)
Arasys Genius is intended for muscle conditioning to stimulate healthy muscles. The Arasys Genius is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physician licensed in the state in which he or she practices. The Arasys Genius is intended to be operated by a trained professional who is always present to monitor treatment.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
...
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
. FOR FDA USE ONLY : : :
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Përia -S
:
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
...
13
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 PRAStaff@fda.hhs.gov
"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."