(457 days)
No
The description focuses on standard TENS/PMS technology and microprocessor control for pulse delivery and intensity adjustment. There is no mention of AI, ML, or any learning/adaptive capabilities.
Yes.
The device is intended for temporary relief of pain and to stimulate muscles, both of which are therapeutic purposes. It is also described as a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), which are types of therapeutic devices.
No
Explanation: The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) used for temporary pain relief and muscle stimulation, not for diagnosing conditions. Its intended use is therapeutic, not diagnostic.
No
The device description explicitly states it is a "double-channel subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin". This indicates the device includes hardware components (microprocessor, electrical pulse delivery system, wires, electrode pads) in addition to any software it may contain.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary relief of pain and muscle stimulation. This involves applying electrical pulses to the body, which is a therapeutic or physical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS). These types of devices deliver electrical stimulation externally to the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a disease or condition based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX
Device Description
The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), intended for the over-the-counter use to temporarily relieve pain and stimulate muscle in different body areas. The double-channel subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief and muscle stimulation. The electrode pad used consists of gel, carbon film, cloth backing, and electrode connector, which is 510(k)-cleared and biocompatible. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, upper extremities (arm), and lower extremities (leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
(a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
(b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
(c) IEC 60601-2-10 "Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators".
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.
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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2014
IQ Technologies, Inc. Elli Josef 1631 E. Sunset Rd., Ste. C 103 Las Vegas, NV 89119
Re: K131290 Trade/Device Name: IO Technologies Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electric nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH: NGX Dated: June 30, 2014 Received: July 2, 2014
Dear Mr. Josef:
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. Isting 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
1
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 You/Industry/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aguel -S
Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K131290
Device Name IQ Technologies
Indications for Use (Describe)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
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)
Date: 2014.08.06 22:22:02 -04'00'
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510(k) Summary
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter's Information
Submitter: IQ Technologies Inc. Address: 1631 E. Sunset Road, C103, Las Vegas, NV 89119 Contact Person: Elli Josef Tel: 702-260-8829 Fax: 702-260-8840 Email: elijosef57@gmail.com Date of Preparation: 04/11/2013
2. Correspondent's Information
Correspondent: IQ Technologies Inc. Address: 1631 E. Sunset Road, C103, Las Vegas, NV 89119 Contact Person: Elli Josef Tel: 702-260-8829 Fax: 702-260-8840 Email: elijosef57@gmail.com
3. Subject Device
Trade/Device Name: IQ Technologies Common Name: Transcutaneous electrical nerve stimulator (TENS) and Powered Muscle Stimulator (PMS) Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter (OTC) Regulation Description: Transcutaneous electrical nerve stimulator for pain relief Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: NUH, NGX Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter
4. Predicate device
Predicate Device: Powered Muscle Stimulator. JO-5C 510(k) Number: K102598 Use: Over-The-Counter Submitter: Hi-Dow International, Inc.
Predicate Device: TENS&PMS 510(k) Number: K121757 Use: Over-The-Counter Submitter: Healthmate International, LLC
5. Description of Subject Device
The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle
4
Stimulator (PMS), intended for the over-the-counter use to temporarily relieve pain and stimulate muscle in different body areas. The double-channel subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief and muscle stimulation. The electrode pad used consists of gel, carbon film, cloth backing, and electrode connector, which is 510(k)-cleared and biocompatible. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.
6. Intended Use of Subject Device
TENS:
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS:
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
7. Summary of Substantial Equivalence
The following table summarizes the comparison between the subject device and predicate devices, indicating the technical characteristics, specifications, and intended use of the subject device are substantially equivalent to those of the predicate devices.
| Subject Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| 510(k) Number | K131290 | K102598 | K121757 |
| Device Name | IQ Technologies | Hi-Dow | HealthmateForever |
| Intended Use | To be used for temporary | ||
| relief of pain associated | |||
| with sore and aching | |||
| muscles in the shoulder, | |||
| waist, back, upper | |||
| extremities (arm), and | |||
| lower extremities (leg) | |||
| due to strain from | |||
| exercise or normal | |||
| household work | |||
| activities. | |||
| It is intended to be used | |||
| to stimulate healthy | |||
| muscles in order to | |||
| improve and facilitate | |||
| muscle performance. | To be used for | ||
| temporary relief of pain | |||
| associated with sore | |||
| and aching muscles in | |||
| the shoulder, waist, | |||
| back, neck, upper | |||
| extremities (arm), and | |||
| lower extremities (leg) | |||
| due to strain from | |||
| exercise or normal | |||
| household work | |||
| activities. | |||
| It is intended to be used | |||
| to stimulate healthy | |||
| muscles in order to | |||
| improve and facilitate | |||
| muscle performance. | To be used for | ||
| temporary relief of pain | |||
| associated with sore | |||
| and aching muscles in | |||
| the shoulder, waist, | |||
| back, neck, upper | |||
| extremities (arm), and | |||
| lower extremities (leg) | |||
| due to strain from | |||
| exercise or normal | |||
| household work | |||
| activities. | |||
| It is intended to be used | |||
| to stimulate healthy | |||
| muscles in order to | |||
| improve and facilitate | |||
| muscle performance. | |||
| Power Source | DC 3.7V Lithium Battery | DC 3.7V Lithium | |
| Battery | DC 3.7V Lithium | ||
| Battery | |||
| Number of Output Channels | 2 | 2 | 2 |
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| Automatic Overload Trip | No | No | No |
|---|---|---|---|
| Automatic No-Load Trip | No | No | No |
| Automatic Shut Off | Yes | Yes | Yes |
| User Override Control | Yes | Yes | Yes |
| Indicator | Yes | Yes | Yes |
| Waveform | Pulsed | Pulsed | Pulsed |
| Shape | Rectangular | Rectangular | Rectangular |
| Maximum output voltage | |||
| (Volts +/- 20%) at 500Ω | Mode 1: 42 | ||
| Mode 2: 63.2 | |||
| Mode 3: 64 | |||
| Mode 4: 34.4 | |||
| Mode 5: 32 | |||
| Mode 6: This mode cycles the above five modes | 62.4 | 70 | |
| Maximum output voltage | |||
| (Volts +/- 20%) at 2KΩ | Mode 1: 80.8 | ||
| Mode 2: 94.4 | |||
| Mode 3: 87.2 | |||
| Mode 4: 68 | |||
| Mode 5: 64 | |||
| Mode 6: This mode cycles the above five modes | 79.2 | 90 | |
| Maximum output voltage | |||
| (Volts +/- 20%) at 10kΩ | Mode 1: 129 | ||
| Mode 2: 129 | |||
| Mode 3: 96.8 | |||
| Mode 4: 128 | |||
| Mode 5: 119 | |||
| Mode 6: This mode cycles the above five modes | 84 | 100 | |
| Maximum output current | |||
| (mA +/- 20%) at 500Ω | Mode 1: 84 | ||
| Mode 2: 126.4 | |||
| Mode 3: 128 | |||
| Mode 4: 68.8 | |||
| Mode 5: 64 | |||
| Mode 6: This mode cycles the above five modes | 124.8 | 140 | |
| Maximum output current | |||
| (mA +/- 20%) at 2KΩ | Mode 1: 40.4 | ||
| Mode 2: 47.2 | |||
| Mode 3: 43.6 | |||
| Mode 4: 34 | |||
| Mode 5: 32 | |||
| Mode 6: This mode cycles the above five modes | 39.6 | 45 | |
| Maximum output current | |||
| (mA +/- 20%) at 10KΩ | 8.4 | 10 | |
| Mode 1: 12.9 | |||
| Mode 2: 12.9 | |||
| Mode 3: 9.7 | |||
| Mode 4: 12.8 | |||
| Mode 5: 11.9 | |||
| Mode 6: This mode cycles the above five modes | |||
| Pulse Width (µSec) | 100 | 100 | 90 |
| Pulse period (mSec) | 10~840 | 16.3~781 | 10~836 |
| Frequency (Hz) | Mode 1: 69.4 | ||
| Mode 2: 12.3~54.3 | |||
| Mode 3: 1.2 | |||
| Mode 4: 100 | |||
| Mode 5: 100 | |||
| Mode 6: This mode cycles the above five modes | 61.3 | 100 | |
| Maximum Phase charge | |||
| (µC) at 500Ω | 16.8 | 17.9 | 15.7 |
| Maximum current density | |||
| (mA/cm²) at 500Ω | Mode 1: 3.36 | ||
| Mode 2: 5.06 | |||
| Mode 3: 5.12 | |||
| Mode 4: 2.75 | |||
| Mode 5: 2.56 | |||
| Mode 6: This mode cycles the above five modes | 9.92 | Mode 1: 6.48 | |
| Mode 2: 5.6 | |||
| Mode 3: 7.2 | |||
| Mode 4: 5.6 | |||
| Mode 5: 5.6 | |||
| Mode 6: This mode cycles the above modes | |||
| Maximum average power | |||
| density (mW/cm²) at 500Ω | Mode 1: 2.11 | ||
| Mode 2: 0.85~3.75 | |||
| Mode 3: 0.08 | |||
| Mode 4: 2.05 | |||
| Mode 5: 1.64 | |||
| Mode 6: This mode cycles the above five modes | 2.72 | Mode 1: 0.52 | |
| Mode 2: 0.39 | |||
| Mode 3: 0.65 | |||
| Mode 4: 0.39 | |||
| Mode 5: 0.39 | |||
| Mode 6: This mode cycles the above modes | |||
| Compliance with Voluntary | |||
| Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 |
| Compliance with 21 CFR | |||
| 898 | Yes | Yes | Yes |
6
8. Substantial Equivalence
The operational principle of the above predicate devices is to generate small pulses of electrical current and delivers the pulses to the user's skin through adhesive electrode pads such that the underlying nerves and/or muscles are activated.
7
Identically, the subject device generates small pulses of electrical current and delivers the pulses to the user's skin through adhesive electrode pads such that the underlying nerves and/or muscles are activated.
The comparison between the subject device and predicate devices demonstrates the technical characteristics, specifications, and intended use of the subject device are substantially equivalent to those of the predicate devices.
The differences, such the output voltage and current, between the subject device and the predicate devices are insignificant in terms of safety or effectiveness. The verification and validation tests, such as IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10, further demonstrate these differences maintain the same safety and effectiveness as those of the 510(k) cleared predicate devices. In other words, these differences do not affect the intended use or alter the fundamental technology of the device. There are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, and effective results as the predicate devices.
Concerns of the safe and proper use of the electrode pads have been fully addressed by making the use conscious of the proper placement of the electrode pads and appropriate operations of the device through details in the labeling. The electrode pads cleared in K090198 are to be used with the subject device.
9. Non-Clinical Tests Performed
The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
- (c) IEC 60601-2-10 "Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators".
In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The biocompatible electrodes, as the accessory of the subject device, also meet the requirement of safety.
10. Conclusion
The tests performed and the comparison of technical characteristics, specifications, and intended use demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the foregoing identified OTC predicate devices that have been legally marketed in the United States.