(56 days)
No
The description details fixed output and waveform characteristics with adjustable intensity and pre-programmed modes. There is no mention of adaptive learning, data analysis for personalized treatment, or any other characteristics typically associated with AI/ML in medical devices.
Yes
The device is described as a "transcutaneous electrical nerve stimulator used for pain relief," and its intended use is for "temporary relief of pain associated with sore and aching muscles." These functions clearly indicate a therapeutic purpose.
No
Explanation: The device, a Transcutaneous Electrical Nerve Stimulator (TENS), is intended for pain relief by applying an electrical current to the skin, not for diagnosing medical conditions. Its function is therapeutic, not diagnostic.
No
The device description explicitly states it consists of a "stimulus generator" and "electrode," which are hardware components. While software is mentioned for control and programming, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a transcutaneous electrical nerve stimulator (TENS). TENS devices work by applying electrical current to the skin to stimulate nerves and block pain signals. This is a physical therapy modality, not a method for diagnosing a condition.
- Lack of Diagnostic Function: The description focuses on the electrical stimulation parameters and how the device delivers current for pain relief. There is no mention of analyzing biological samples (like blood, urine, or tissue) or providing information about a patient's health status or disease.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The Gemore OTC TENS, Model GM310PP/GM321PP/GM330PP, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities
Product codes
NUH
Device Description
The Gemore OTC TENS. model GM310PP/GM321PP/GM321PP/GM330PP is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit.
The Gemore OTC TENS, model GM310PP/GM320PP/GM321PP/GM330PP, consist mainly of two parts: the stimulus generator, electrode. The stimulus generates the output current specified as the innut of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief.
The stimulation modes for Gemore OTC TENS is pre-program modes width, pulse rate, frequency. The timer and amplitude for each program are adjustable. This operation way is considered the simplification from the pre-program modes of comparison clear model, OTC TENS For Low Back Pain Relief/ Model GM310PP/GM320PP /GM321PP/ GM330PP (K060222). Every operation mode of Gemore OTC TENS, model GM310PP/GM320PP/ GM321PP/GM330PP has its individual stimulation operation cycle.
For the device included in this submission, we use the following of our 510(K) legally marketed electrodes: K062675, "Gemore Reusable Self Adhesive Electrode", Wire Series/ model no. FA5050, size 50x50mm, wire type.
With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
low back as well as upper and lower extremities (arm and/or leg)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Compliance to applicable voluntary standards includes IEC 60601-1, and IEC 60601-1, and IEC 60601-1-2 as well as ISO 10993-5 and ISO 10993-10 requirements. In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
Summary: The Compliance to applicable voluntary standards as above mentioned indicates that the new device in this submission used the same standards as that of predicate device. Therefore; we consider that the compliance of standards included in our submission is adequate for the determination of substantial equivalence.
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
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2015
Gemore Technology Co., Ltd. Boden Lai Official Correspondent 11 Fl., No.29-5, Sec.2, Chung Cheng E. Rd., Tan Shui, New Taipei City, 251 TW
Re: K150681
Trade/Device Name: Gemore OTC TENS, Models GM310PP/GM320PP/GM321PP/GM330PP Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: NUH Dated: March 16, 2015 Received: March 17, 2015
Dear Boden Lai:
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
1
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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
for Carlos L. Peña, PhD, MS 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): K150681
Device Name: Gemore OTC TENS, Model GM310PP/GM320PP/GM321PP/GM330PP
Indications For Use:
The Gemore OTC TENS, Model GM310PP/GM321PP/GM330PP, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities
Prescription Use (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K 150681 .
-
Submitter's Identifications: 1.
Company Name : GEMORE TECHNOLOGY CO., LTD. Contact person: Boden S.P. Lai 11FL., NO. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, New Taipei City, Taiwan Address : TEL No. : 886-2-8809-1799 Fax No. : 886-2-8809-1781 boden@gemore.com.tw E-mail address : Date of Summary Preparation: April 27, 2015. -
- Name of the Device:
Trade/Device Name: Gemore OTC TENS, Model: GM310PP/GM320PP/GM321PP/GM330PP. Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator. Regulatory Class: II Product Code: NUH
- Name of the Device:
-
Information of the 510(k) Cleared Device (Predicate Device): 3. K133723: OTC Patch/ Model WL-2406. K091757: OTC TENS For Arm & Leg Pain Relief/ Model WL-2407
-
- Device Description:
The Gemore OTC TENS. model GM310PP/GM321PP/GM321PP/GM330PP is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit.
The Gemore OTC TENS, model GM310PP/GM320PP/GM321PP/GM330PP, consist mainly of two parts: the stimulus generator, electrode. The stimulus generates the output current specified as the innut of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief.
The stimulation modes for Gemore OTC TENS is pre-program modes width, pulse rate, frequency. The timer and amplitude for each program are adjustable. This operation way is considered the simplification from the pre-program modes of comparison clear model, OTC TENS For Low Back Pain Relief/ Model GM310PP/GM320PP /GM321PP/ GM330PP (K060222). Every operation mode of Gemore OTC TENS, model GM310PP/GM320PP/ GM321PP/GM330PP has its individual stimulation operation cycle.
For the device included in this submission, we use the following of our 510(K) legally marketed electrodes: K062675, "Gemore Reusable Self Adhesive Electrode", Wire Series/ model no. FA5050, size 50x50mm, wire type.
With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
4
5. Intended Use:
The Gemore OTC TENS, Model GM310PP/GM321PP/GM330PP, is intended for temporary relief of pain associated with sore and aching muscles in the low back and/or upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
6. Summary of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes IEC 60601-1, and IEC 60601-1, and IEC 60601-1-2 as well as ISO 10993-5 and ISO 10993-10 requirements. In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
Summary: The Compliance to applicable voluntary standards as above mentioned indicates that the new device in this submission used the same standards as that of predicate device. Therefore; we consider that the compliance of standards included in our submission is adequate for the determination of substantial equivalence.
7. Comparison of Significant device features
| Features | 510(K) Cleared Models | New Model | |
|---|---|---|---|
| Model | WL-2406 | WL-2407 | GM310PP/GM320PP/ |
| GM321PP/GM330PP | |||
| 510(K) No. | K133723 | K091757 | Unknown |
| Prescription or OTC | OTC | OTC | OTC |
| Indication for use | temporary relief of pain | ||
| associated with sore and | |||
| aching muscles in the low | |||
| back as well as upper and | |||
| lower extremities (arm and/ | |||
| or leg) due to strain from | |||
| exercise or normal House- | |||
| hold and work activities | temporary relief of pain | ||
| associated with sore and | |||
| aching muscles in the upper | |||
| And lower extremities (arm | |||
| and/or leg) due to strain from | |||
| exercise or normal House- | |||
| hold and work activities | temporary relief of pain | ||
| associated with sore and | |||
| aching muscles in the low | |||
| back as well as upper and | |||
| lower extremities (arm and/ | |||
| or leg) due to strain from | |||
| exercise or normal House- | |||
| hold and work activities | |||
| FDA product code | NUH | NUH | NUH |
| Electrode Used | Self Adhesive Electrode | ||
| (13x7 cm)/K082065 | Belt Electrode and/or | ||
| Self Adhesive Electrode | |||
| (5 X 5 cm)/K082065 | Self Adhesive Electrode | ||
| (5x5 cm)/K062675 |
8. Significant output characteristics comparison table:
| Comparison feature | 510(K) Cleared Model | New Model | ||
|---|---|---|---|---|
| WL-2406(K133723) | WL-2407(K091757) | GM310PP/GM320PP/ | ||
| GM321PP/GM330PP | ||||
| Net charge | 0 | 0 | 0 | |
| Max. phase charge | 13 uc | 20.8 uc | 20.8 uc | |
| Max. current Density | 0.549 mA/cm² | 3.2 mA/cm2 | 3.2 mA/cm2 | |
| Max. Average | 500 입 | 50 mA | 80 mA | 80 mA |
| current | 2K S2 | 22.5 mA | 30 mA | 40 mA |
| (RMSA) | 10K ක | 7.5 mA | 10 mA | 10 mA |
| Max. Power Density | 0.001219 Watts/ cm² | 0.00200 Watts/ cm² | 0.00399 Watts/ cm2 | |
| Burst Mode | Yes | Yes | Yes | |
| Predicate Device | New Device | |||
| Mode or Program Name | WL-2406 | WL-2407 | GM310PP/GM320PP/ | |
| GM321PP/GM330PP | ||||
| 510(K) Number | K133723 | K091757 | Unknown | |
| Waveform (e.g., pulsed monophasic, biphasic) | Biphasic | Biphasic | Pulsed monophasic | |
| Shape (e.g., rectangular, spike, rectified | ||||
| sinusoidal) | Rectangular | Rectangular | Rectangular | |
| Maximum Output Voltage (volts) | ||||
| (+/-_20 %) | 25V @500Ω | 40V @500Ω | 40V @500Ω | |
| 45V @2KΩ | 60V @2KΩ | 80V @2KΩ | ||
| 75V @10KΩ | 100V @10KΩ | 100V @10KΩ | ||
| Maximum Output Current (mA) | ||||
| (+/-_20 %) | 50mA @500Ω | 80mA @500Ω | 80mA @500Ω | |
| 22.5mA @2KΩ | 30mA @2KΩ | 40mA @2KΩ | ||
| 7.5mA @10KΩ | 10mA @10KΩ | 10mA @10KΩ | ||
| Duration of primary phase (usec) | 260 max | 260 max | 260 max | |
| Pulse Duration (usec) | 8333 max | 16666 max | 8333 max | |
| Frequency (Hz) [or Rate (pps)] | 120 max | 60 max | 120 max | |
| For | Yes | Yes | Yes | Yes |
| multiphasic | ||||
| waveforms | ||||
| only: | Not applicable | Not applicable | Not applicable | Not applicable |
| Power Source(s) | 1.5Vx2 | |||
| (AAA Size) | 1.5Vx3 | |||
| (AAA Size) | 9V x 1 | |||
| (6F22 Size) | ||||
| - Method of Line current Isolation | Type BF | Type BF | Type BF | |
| - Patient Leakage Current | --- | --- | --- | |
| - Normal condition (uA) | Under 0.1 | Under 0.1 | Under 0.1 | |
| - single Fault condition (uA) | Under 0.5 | Under 0.5 | Under 0.5 | |
| Average DC current through electrodes when | ||||
| device is on but no pulses are being applied (uA) | Not applicable | Not applicable | Not applicable | |
| Number of Output Modes | 8 | 8 | 8 | |
| Number of Output | ||||
| Channels: | Synchronous | |||
| Output Coil | Synchronous | |||
| Output Coil | Synchronous | |||
| Output Coil | Synchronous | |||
| Transformer | ||||
| Regulated Current or Regulated Voltage? | Voltage | Voltage | Current | |
| Software/Firmware/Microprocessor control? | Yes | Yes | Yes | |
| Automatic Overload Trip? | No | No | No | |
| Automatic No-Load Trip? | Yes | Yes | Yes | |
| Automatic Shut Off? | Yes | Yes | Yes | |
| User Override control? | No | No | No | |
| Indicator Display: | Yes | Yes | Yes | |
| Yes | Yes | Yes | ||
| Yes | Yes | Yes | ||
| Timer Range (Minutes) | 10-60 | 5-60 | 10-60 and Continuous | |
| Compliance with Voluntary Standards? | IEC 60601-2-10 | IEC 60601-2-10 | IEC 60601-2-10 | |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | |
| Weight (g) including battery | 51.6 | 125.5 | 140 | |
| Dimensions (mm.) [W x H x D] | 68x60x17.5 | 90×50.8×12.7 | 108×61.5×25 | |
| Housing Materials and construction | ABS | ABS | ABS | |
| Pulse per burst | 9 | 9 | 9 | |
| Burst per second | 2 | 2 | 2 | |
| Bust duration | 260us | 260us | 260us | |
| Duty Cycle | Same for each | |||
| program | Same for each | |||
| program | Same for each | |||
| program | ||||
| Method of achieving zero net charge for net | ||||
| charge/pulse | Biphasic | |||
| symmetric | ||||
| wave for each | ||||
| pulse | Biphasic symmetric | |||
| wave for each pulse | Biphasic | |||
| asymmetric | ||||
| wave for each pulse |
5
9. Comparison of Unit Characteristics & Output Specification
6
10. Summary for the technology comparison.
Basically the Gemore OTC TENS, Model GM310PP/GM321PP/GM321PP/GM330PP has the same technological characteristics with the predicate device in the product design, material, energy source type, main program mode and the main output waveform...etc. There exists some difference in the device outlook and dimensions. Through the detailed calculation comparison of stimulation output energy for each operation mode(in particular the output current density and power density), we found the output level in each operation mode for Gemore OTC TENS, Model GM310PP/GM320PP/GM321PP/GM330PP and predicate device are very close and within the acceptable range as specified in FDA quidance. So we believe the difference in detailed output parameters does not affect the determination of substantial equivalence.
11. Conclusions
The Gemore OTC TENS, Model GM310PP/GM320PP/GM330PP have the same intended use and the similar technological characteristics as the cleared devices. Moreover, verification and validation tests contained in this submission demonstrate that the submitted models could maintain the same safety and effectiveness as that of cleared device.
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.