The model GM310PP, GM320PP, GM321PP, and GM321PP are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

Device Description

The Gemore Low Back Pain Relief System, models GM310PP, GM320PP, GM321PP, and GM330PP are non-invasive devices which are intended for over the counter use in temporary relief of pain associated with sore and aching muscles in the lower back due to stain from exercise or normal household and work activities.

The devices contain the following main parts: TENS stimulation unit, Support Belt, Self-adhesive pads, and Snap Cable.

The device can be worn on the low back part of user so as to place the stimulation pads on the treatment location of low back.

The main stimulation function is achieved through the stimulation unit of GM310PP, GM320PP, GM321PP, and GM330PP. Those stimulation units have been cleared for 510(k) before being submitted on this new submission for OTC application. The K-number for these four models are K032720.

AI/ML Overview

The provided 510(k) summary for the "Low Back Pain Relief System, model GM310PP, GM320PP, GM321PP, and GM330PP" indicates that its acceptance criteria and clinical performance were established through a substantial equivalence pathway, rather than a de novo study with specific performance targets. This means the device's safety and effectiveness are demonstrated by showing it is as safe and effective as a legally marketed predicate device.

Here's an analysis based on the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Technological Equivalence to Predicate Device: The device must demonstrate similar technological characteristics to its predicate device, with differences being insignificant and not affecting safety or effectiveness.	"A comparison of the technological characteristics of the Gemore models GM310PP, GM320PP, GM321PP, and GM330PP and the predicate device has been performed. The results of this demonstrate that the Gemore model GM310PP, GM320PP, GM321PP, and GM330PP are equivalent to the marketed predicate device. The differences... are insignificant and do not affect the safety or effectiveness of the device."
Intended Use Equivalence: The device must share the same intended use as its predicate.	The intended use statement for GM310PP, GM321PP, and GM330PP ("temporary relief of pain associated with sore and aching muscles in the low back due to strain from exercise or normal household and work activities") aligns with the predicate device, K040512.
Safety Testing (Electrical Safety): Compliance with relevant safety standards for Transcutaneous Electrical Nerve Stimulators (TENS) units.	"The performance testing reports according to ANSI/AAMI NS4, and the safety testing reports according to EN 60601-1, EN 60601-1-1, and EN 60601-1-2 as mentioned in the previous 510(k) submission documents are still available for this submission." (Referring to K032720 for the core stimulation units).
Biocompatibility Testing (for additional components): Compliance with relevant biocompatibility standards for components that come into contact with the skin.	"For the additional fixing part, the neoprene belt, the bio-compatibility testing report done according to ISO 10993-1 as well as the relevant standards are included in this submission."
Overall Substantial Equivalence: The device must be deemed substantially equivalent to a legally marketed predicate device.	"Gemore Technology Inc, has demonstrated through its evaluation of the Gemore models GM310PP, GM320PP, GM321PP, and GM330PP that the devices are equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness." This conclusion was affirmed by the FDA's 510(k) clearance letter (K060222).

2. Sample Size Used for the Test Set and Data Provenance

This submission does not refer to a "test set" in the context of clinical performance data generated specifically for this device (GM310PP, GM320PP, GM321PP, GM330PP).

Instead, the submission relies on:

Previous 510(k) submissions (K032720) for the core TENS stimulation units (GM310PP, GM320PP, GM321PP, GM330PP) for their performance and safety testing. The specific details of any clinical "test set" from K032720 are not provided in this document.
Bench testing and materials characterization for the new components (e.g., neoprene belt). These are not clinical studies with human subjects for efficacy.

Therefore, information regarding country of origin of data or retrospective/prospective nature is not applicable for a direct clinical test set for this specific 510(k) submission. It's an affirmation of equivalence based on existing data and bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This substantial equivalence submission does not describe a clinical study that required expert consensus for ground truth on human subjects. The "ground truth" here is compliance with established engineering and biocompatibility standards, and the predicate's known safety and performance.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication of results from multiple readers/observers is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done for this device. The submission relies on demonstrating equivalence to an already marketed device, not on showing human reader improvement with or without AI assistance. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI-powered diagnostic system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical device (TENS unit) for pain relief, not an algorithm, and thus standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

Compliance with recognized voluntary consensus standards: ANSI/AAMI NS4 (performance for TENS), EN 60601-1 series (electrical safety), and ISO 10993-1 (biocompatibility).
Demonstrated safety and effectiveness of the predicate device (K040512). The predicate device serves as the benchmark against which substantial equivalence is claimed.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established in that context.

Summary

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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: _______________________________________________________________________________________________________________________________________________

1. Submitter's Identifications:
  GEMORE TECHNOLOGY CO., LTD. Company Name : Boden S.P. Lai Contact person: 11FL., NO. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan Address : 886-2-8809-1799 TEL No. : 886-2-8809-1781 Fax No. : gemore@anet.net.tw E-mail address :

Date of Summary Preparation: January 24, 2006.

Device Identification: Classification Name: Transcutaneous Nerve Stimulator. Grassliteation Name: Low Back Pain Relief System, model GM310PP, GM321PP, GM321PP, and GM330PP. Classification: Class II (21 CFR 882.5890) Product Code: GZJ & NUH

1. Identification of predicate device
  The Gemore Low Back Pain Relief System models GM310PP, GM320PP, GM321PP, and GM330PP are of comparable type and are substantially equivalent to the following predicate devices:
K040512: Limit Function WL/OTC-TENS/Model WL-2403.
1. Device Description:
  Device Describition:
  The Gemore Low Back Pain Relief System, models GM310PP, GM320PP, GM321PP, and r in Comford Love invasive devices which are intended for over the counter use in temporary relied of pain associated with sore and aching muscles in the lower back due to stain from exercise or normal household and work activities.

The devices contain the following main parts: TENS stimulation unit, Support Belt, Self-adhesive pads, and Snap Cable.

The device can be worn on the low back part of user so as to place the stimulation pads on the treatment location of low back.

For the detail description of these four stimulation models, please refer to the information provided in K032720.

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5. Intended Use:

The models GM310PP, GM321PP, and GM330PP are indicated for over the counter use in the temporary relief of pain associated with sore and aching muscles in the low back due to stain from exercise or normal household and work activities.

For the indication for use statement, please see the information attached hereafter.

6. Technological characteristics:

A comparison of the technological characteristics of the Gemore models GM310PP, GM320PP, GM321PP, and GM330PP and the predicate device has been performed. The results of this demonstrate that the Gemore model GM310PP, GM320PP, GM321PP, and GM330PP are equivalent to the marketed predicate device. The differences between the Gemore models GM310PP, GM321PP, GM321PP, and GM330PP and the predicate models are insignificant and do not affect the safety or effectiveness of the device.

7. Performance data:

Since there is not any significant change in the construction specification for the main stimulation unit GM310PP. GM321PP. GM321PP. and GM330PP. the performance testing reports according to ANSI/AAMI NS4, and the safety testing reports according to EN 60601-1, EN 60601-1-1, and EN 60601-1-2 as mentioned in the previous 510(k) submission documents are still available for this submission.

For the additional fixing part, the neoprene belt, the bio-compatibility testing report done according to ISO 10993-1 as well as the relevant standards are included in this submission.

8. Conclusions

Gemore Technology Inc, has demonstrated through its evaluation of the Gemore models GM310PP, GM320PP, GM321PP, and GM330PP that the devices are equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2006

Gemore Technology Co., Ltd. c/o Boden S.P. Lai 11 FL., NO. 29-5, Sec. 2 Chung Cheng E. RD. Tan Shui, Taipei Hsien, Taiwan

Re: K060222

Trade/Device Name: Low Back Pain Relief System, model numbers GM310PP, GM320PP, GM321PP, and GM330PP Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: January 27, 2006 Received: January 30, 2006

Dear Mr. Lai:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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.

If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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); good manufacturing practice

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Page 2 - Boden S.P. Lai

requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Herbert Lemmer

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known):

Device Name: Low Back Pain: Relief System / Model: GM310PP, GM320PP, GM321PP, and GM330PP.

Indications For Use:

The model GM310PP, GM320PP, GM321PP, and GM321PP are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use V (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)

Hulut Lermuica

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_KO60222

Regulation Number and Section

§ 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).