(144 days)
No
The description details a standard TENS device with adjustable parameters and pre-set modes, but there is no mention of AI or ML capabilities for learning, adapting, or making decisions based on patient data or feedback. The software change mentioned is likely related to the indication for use, not the incorporation of AI/ML.
Yes
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) System, which is indicated for the symptomatic relief of chronic, intractable pain, adjunctive treatment for post-surgical and post-traumatic acute pain, and relief of pain associated with osteoarthritis and rheumatoid arthritis. These are all therapeutic uses.
No
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) system intended for pain relief by applying electrical current, not for diagnosing conditions.
No
The device description explicitly states it consists of a "stimulus generator and electrode" and is an "electrically power device," indicating it includes hardware components beyond just software. While the software was changed, the device itself is not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states the device is for "symptomatic relief of chronic, intractable pain," "adjunctive treatment for post-surgical and post-traumatic acute pain," and "relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the hand." These are all therapeutic applications, not diagnostic ones.
- Device Description: The description details how the device applies electrical current to the skin for pain relief. This is a physical intervention, not a test performed on biological samples.
- FDA Classification: The device is classified under 21CFR/Part 882.5890 with product codes "NYN" & "GZJ". These classifications are for neurological devices, specifically Transcutaneous Electrical Nerve Stimulators (TENS), which are therapeutic devices. IVD devices have different classification numbers and product codes.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic purposes, or any of the typical components or processes associated with IVD devices.
In summary, the GEMORE TENS System is a therapeutic device used for pain relief, not a diagnostic device used to test biological samples.
N/A
Intended Use / Indications for Use
The GEMORE TENS System, model GM310TP/GM320TP/GM330TP/GM340TP Transcutaneous Electrical Nerve Stimulators are indicated for:
- symptomatic relief of chronic, intractable pain .
- adjunctive treatment for post-surgical and post-traumatic acute pain
- relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the hand
Product codes (comma separated list FDA assigned to the subject device)
GZJ, NYN
Device Description
The Gemore TENS System / Model GM310TP, GM320TP, GM330TP, and GM340TP transcutaneous electrical nerve stimulators for pain relief, are the electrically power devices used to apply an electrical current to electrode on a patient's skin to relieve pain.
The Gemore TENS system consists mainly of two parts: the stimulus generator and electrode. The stimulus generator generates the output current specified as the input of controller. The output of controller is able to be adjusted for B/C/M/P1/P2/P3/P4/P5 eight operation modes which bear different combination for the output parameters of pulse width, pulse rate, and pulse cycle. For every operation mode, the operator could adjust output intensity, pulse rate and operation time. The output parts transmit the output current to the electrodes which is attached to the patient's skin so as to transmit the generated stimulus to patient for pain relief treatment.
GM310TP/GM320TP/GM330TP/GM340TP is completely identical to that of model as mentioned in our previous submission of GEM STIM TENS, model GM310TE/ GM320TE/GM330TE/GM340TE (K032720). To change the indication for use as that of the chosen predicate devices, Gemore changed the software for these four models.
GM310TP/GM320TP/GM330TP/GM340TP is a selectable dual channel, 9V battery operated TENS device with the following features:
- The operation function is dual channels completely identical to the model being modified, GM310TE/GM320TE/GM330TE/GM340TE (K032720).
- The output of controller is able to be adjusted for B/C/M/P 1/P2/P3/P4/P5 eight operation modes which bear different combination for the output parameters of pulse width, pulse rate, and pulse cvcle.
- The output strength is adjustable at 0~80 mA, with maximum setting time 60 minutes counting from switching ON.
- The LCD display is provided for the indication of operation status including CH1/CH2, output program mode, pulse width, pulse rate, timer, and battery low warning
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ANSI/AAMI. NS4-1985, as well as IEC 60601-1, and IEC 60601-1-2 requirement. In addition to compliance of the voluntary standards, the software verification has been carried out in accordance to the FDA software guidance.
The GEMORE TENS System, model GM310TP/GM320TP/GM330TP/GM340TP have the same technological characteristics as the of the 510(K) cleared device, the Empi - SELECT TENS System. (K061650). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted model 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.
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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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: K120569 .
-
- Submitter's Identifications: Gemore Technology Co., Ltd. 11FL., NO. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan
Contact: Boden S.P. Lai / President & Official Correspondent Phone Number:886-2-8809-1799 Fax Number:886-2-8809-1781
- Submitter's Identifications: Gemore Technology Co., Ltd. 11FL., NO. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan
Date of Summary Preparation: July 12, 2012.
-
- Name of the Device:
| Trade name: | GEMORE TENS System; models GM310TP/GM320TP/
GM330TP/GM340TP |
|----------------------|----------------------------------------------------------------|
| Common name: | Stimulator, Nerve, Transcutaneous For Pain Relief. |
| Classification name: | Stimulator, Nerve, Transcutaneous For Pain Relief. |
| Product Code: | GZJ & NYN |
3. Information of the 510(k) Cleared Device (Predicate Device):
For this 510(k) submission, we compared our models to the following FDA cleared TENS devices: - K061650: Empi - SELECT TENS System.
4. Device Description:
The Gemore TENS System / Model GM310TP, GM320TP, GM330TP, and GM340TP transcutaneous electrical nerve stimulators for pain relief, are the electrically power devices used to apply an electrical current to electrode on a patient's skin to relieve pain. This series of TENS devices are indicated for:
- symptomatic relief of chronic, intractable pain
- . adjunctive treatment for post-surgical and post-traumatic acute pain
. relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the hand For this definition of intended use, the Gemore TENS system is classified with the "NYN" & "GZJ" product code under 21CFR/Part 882.5890 FDA regulation classification number.
1
Gemore Technology Co., Ltd.
The Gemore TENS system consists mainly of two parts: the stimulus generator and electrode. The stimulus generator generates the output current specified as the input of controller. The output of controller is able to be adjusted for B/C/M/P1/P2/P3/P4/P5 eight operation modes which bear different combination for the output parameters of pulse width, pulse rate, and pulse cycle. For every operation mode, the operator could adjust output intensity, pulse rate and operation time. The output parts transmit the output current to the electrodes which is attached to the patient's skin so as to .transmit the generated stimulus to patient for pain relief treatment.
GM310TP/GM320TP/GM330TP/GM340TP is completely identical to that of model as mentioned in our previous submission of GEM STIM TENS, model GM310TE/ GM320TE/GM330TE/GM340TE (K032720). To change the indication for use as that of the chosen predicate devices, Gemore changed the software for these four models.
For the device included in this submission, we use the following of our 510(K) legally marketed predicate garment electrodes:
-
K062675, "Gemore Reuseable Self Adhesive Electrode" ; Wire Series/ Model FA5050 ( 5x5 CM or bigger size) self adhesive electrode.
GM310TP/GM320TP/GM330TP/GM340TP is a selectable dual channel, 9V battery operated TENS device with the following features: -
The operation function is dual channels completely identical to the model being modified, GM310TE/GM320TE/GM330TE/GM340TE (K032720).
-
The output of controller is able to be adjusted for B/C/M/P 1/P2/P3/P4/P5 eight operation modes which bear different combination for the output parameters of pulse width, pulse rate, and pulse cvcle.
-
The output strength is adjustable at 0~80 mA, with maximum setting time 60 minutes counting from switching ON.
-
The LCD display is provided for the indication of operation status including CH1/CH2, output program mode, pulse width, pulse rate, timer, and battery low warning
5. Intended Use:
The indication for use is defined by the following statement:
The GEMORE TENS System, model GM310TP/GM320TP/GM330TP/GM340TP Transcutaneous Electrical Nerve Stimulators are indicated for:
- symptomatic relief of chronic, intractable pain
- . adjunctive treatment for post-surgical and post-traumatic acute pain
- relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the . hand
-
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ANSI/AAMI. NS4-1985, as well as IEC 60601-1, and IEC 60601-1-2 requirement. In addition to compliance of the voluntary standards, the software verification has been carried out in accordance to the FDA software guidance.
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7. Similarities and differences comparison:
For the similarities and differences comparison between the application model GM310TP/ GM320TP/GM340TP and predicate 510(K) cleared model, the Emip-select TENS System, please see the details of the following table:
| Comparison features | Gemore Model | Predicate 510(K) cleared Model |
|---|---|---|
| Model Name | GEMORE TENS System, model | |
| GM310TP/ GM320TP/ GM330TP/ | ||
| GM340TP | Emip-Select TENS System | |
| 510(K) number | K120569 | K061650 |
| Indication for use | indicated for: | |
| • symptomatic relief of chronic, | ||
| intractable pain | ||
| • adjunctive treatment for | ||
| post-surgical and post-traumatic | ||
| acute pain | ||
| • relief of pain associated with | ||
| osteoarthritis of the knee and | ||
| rheumatoid arthritis of the hand | used for the symptomatic relief and | |
| management of chronic, intractable | ||
| pain and pain associated with | ||
| arthritis. They are also used as an | ||
| adjunctive treatment for post-surgical | ||
| and post-trauma acute pain | ||
| Product Code | GZJ & NYN | Same |
| Program mode | B/C/M and P1~P5 pre-program mode | |
| (Note: The program mode is similar | ||
| to predicate device) | B/C/M & ARB/SMP/MA/SPM | |
| preprogram mode | ||
| Conformance standards | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| ANSI/AAMI NS4 | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| Outlook & Dimensions | 108x61.5x25 mm | 109.5x60x34.9 mm |
| Weight | 140 g | 138.9 g |
8. Comparision for the basic unit characteristics : As the following table
| Parameter | New Device | Predicate Device | |
|---|---|---|---|
| 510(K) Number | K120569 | K061650 | |
| Device Name and Model | GEMORE TENS | ||
| System | SELECT TENS | ||
| System | |||
| Manufacturer | Gemore | Empi | |
| Power Source(s) | 9V battery | 1.5Vx2 (AA Size) | |
| - Method of Line current Isolation | Type BF | Same | |
| - Patient Leakage Current | --- | ||
| - Normal condition (uA) | Under 0.1 | Same | |
| - single Fault condition (uA) | Under 0.5 | Same | |
| Average DC current through electrodes when | |||
| device is on but no pulses are being applied | Not applicable | Same | |
| (UA) | |||
| Number of Output Modes | 2 | Same | |
| Number of | Synchronous or Alternating ? | Synchronous | Same |
| Output | Method of Channel Isolation | Output transformer | Same |
| Channels: | |||
| Regulated Current or Regulated Voltage? | Current | Same | |
| Software/Firmware/Microprocessor control? | Yes | Same | |
| Automatic Overload Trip? | No | Same | |
| Automatic No-Load Trip? | No | Same | |
| Automatic Shut Off? | Yes | Same | |
| User Override control? | No | Same | |
| Indicator | On/Off Status? | Yes | Same |
| Display: | Low Battery? | Yes | Same |
| Voltage/Current Level? | No | Same | |
| Timer Range (Minutes) | 15,30, and 60 | 1~60 | |
| Compliance with Voluntary Standards? | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| ANSI/AAMI NS4. | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| Compliance with 21 CFR 898? | Yes | Same | |
| Weight (g) | 140 | 138.9 | |
| Dimensions (mm.) [W x H x D] | 108x61.5x25 | 109.5x60.3x34.9 | |
| Housing Materials and construction | ABS | Same |
3
9. Comparison of Output Specification : As the following table
Maximum output specification:
| Parameter | Your Device | Predicate Device |
|---|---|---|
| Mode or Program Name | GM320TP as representative | SELECT TENS System |
| Waveform (e.g., pulsed monophasic, biphasic) | Monophasic | Same |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | Same |
| Maximum Output Voltage (volts) (+/- 20 %) | 40V @500Ω | |
| 96V @2k Ω | ||
| 110V @10k Ω | 26V @500Ω | |
| 40V @2k Ω | ||
| 40V @10k Ω | ||
| Maximum Output Current (specify units) (+/- 20 %) | 80mA @500Ω | |
| 48mA @2k Ω | ||
| 11mA @10k Ω | 52mA @500Ω | |
| 20mA @2k Ω | ||
| 4mA @10k Ω | ||
| Duration of primary (depolarizing) phase (usec) | 260 (usec) Max | 400 (usec) Max |
| Pulse Duration (usec) | 260 Max | 400 Max |
| Frequency (Hz) [or Rate (pps)] | 160 Max | 150 Max |
| For multiphasic | ||
| waveforms only: | Symmetrical phases? | No |
| Same | ||
| Phase Duration (include units), | ||
| (Stage range, if applicable), (both | ||
| phases, if asymmetrical) | Not Applicable | |
| Same |
Detailed comparison for each operation mode:
| Max Phase Charge | Max Current Density | Max Avg Current | Max Power Density | Operation | ||||
|---|---|---|---|---|---|---|---|---|
| Gemore | Emip | Gemore | Emip | Gemore | Emip | Gemore | Emip | Mode |
| 20.8uQ | 20.8uQ | 0.083 | 0.1248 | 2.08 mA | 3.12 mA | 0.0033 | 0.0037 | B |
| mA/cm² | mA/cm² | w/ cm² | w/ cm² | |||||
| 20.8uQ | 20.8uQ | 0.133 | 0.1248 | 3.328 mA | 3.12 mA | 0.0053 | 0.0037 | C |
| mA/cm² | mA/cm² | w/ cm² | w/ cm | |||||
| 20.8uQ | 20.8uQ | 0.133 | 0.1248 | 3.328 mA | 3.12 mA | 0.0053 | 0.0037 | M |
| mA/cm² | mA/cm² | w/ cm² | w/ cm² | |||||
| 20.8uQ | 20.8uQ | 0.133 | 0.1248 | 3.328 mA | 13.12 mA | 0.0053 | 0.0037 | Pl |
| mA/cm2 | mA/cm² | w/ cm- | w/ cm² | |||||
| 20.8uQ | 20.8uQ | 0.133 | 0.1248 | 3.328 mA | 3.12 mA | 0.0053 | 0.0037 | P2 |
| mA/cm² | mA/cm² | w/ cm2 | w/ cm² | |||||
| 20.8uQ | 20.8uQ | 0.133 | 0.1248 | 3.328 mA | 3.12 mA | 0.0053 | 0.0037 | p3 |
| mA/cm² | mA/cm² | w/ cm | w/ cm- | |||||
| 20.8uQ | 20.8uQ | 0.133 | 0.1248 | B.328 mA | 3.12 mA | 0.0053 | 0.0037 | P4 |
| mA/cm² | mA/cm² | w/ cm² | w/ cm | |||||
| 20.8uQ | 20.8uQ | 0.133 | 0.1248 | 3.328 mA | 3.12 mA | 0.0053 | 0.0037 | િર |
| mA/cm2 | mA/cm² | w/ cm² | w/ cm |
10. Conclusions
.
The GEMORE TENS System, model GM310TP/GM320TP/GM330TP/GM340TP have the same technological characteristics as the of the 510(K) cleared device, the Empi - SELECT TENS System. (K061650). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted model 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. Therefore, the GEMORE TENS System, model GM310TP/GM320TP/GM330TP/GM340TP are substantial equivalent to the chosen predicate model.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
GEMORE TECHNOLOGY CO., LTD. c/o Mr. Boden S.P. Lai General Manager 11 FL. No. 29-5, Sec. 2 Chung Cheng E. Rd. Tan Shui, Taipei Hsien Taiwan 251
JUL 2 0 2012
Re: K120569
Trade/Device Name: GEMORE TENS System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ, NYN Dated: July 13, 2012 Received: July 16, 2012
Dear Mr. 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, 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 (Spècial 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
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Page 2 - Mr. Boden S.P. Lai --
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications For Use
510(k) Number (if known): K120569
Device Name: GEMORE TENS System, model GM310TP/GM320TP/ GM330TP/GM340TP
Indications For Use:
The GEMORE TENS System, model GM310TP/GM320TP/GM330TP/GM340TP Transcutaneous Electrical Nerve Stimulators are indicated for:
- symptomatic relief of chronic, intractable pain .
- adjunctive treatment for post-surgical and post-traumatic acute pain
- relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the hand
Prescription Use V (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)
Division Sra-Offi
(Division Siza-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of
510(k) Nomb