(82 days)
Not Found
No
The summary describes a standard TENS device generating electrical pulses for pain relief, with no mention of AI or ML capabilities.
Yes
The device is described as a TENS device used for symptomatic relief and management of chronic pain, which is a therapeutic purpose.
No
The device description states its purpose is for "symptomatic relief and management of chronic intractable pain" through electrical current stimulation to "relieve" pain. This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "high voltage TENS device" that "generates twin high voltage pulses of electrical current" and includes a "cable and electrode". This indicates a hardware component is essential to its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "symptomatic relief and management of chronic intractable pain" by delivering electrical current to the patient's skin and nerves. This is a therapeutic application, not a diagnostic one.
- Device Description: The device generates electrical pulses for stimulation, which is a physical intervention on the body. IVDs, on the other hand, are used to examine specimens taken from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or any other typical IVD processes.
Therefore, the GM3X3HV is a therapeutic device, specifically a TENS (Transcutaneous Electrical Nerve Stimulation) device, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is an high voltage TENS device with TENS indications used for symptomatic relief and management of chronic intractable pain.
Product codes
GZJ
Device Description
The GM3X3HV is the device which generates twin high voltage pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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: ______________________________________________________________________________________________________________________________________________
DEC 1 6 2003
Submitter's Identifications: 1. GEMORE TECHNOLOGY CO., LTD. 11FL., NO. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan
Contact: Boden S.P. Lai General Manager
Date of Summary Preparation: September 15, 2003.
2. Name of the Device:
GEM-HV TENS (Also known as GEM-PGS TENS), High Voltage TENS Device / Model; GM3X3HV, where X is the parameter for different housing.
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- Information of the 510(k) Cleared Device (Predicate Device):
PGS123 (K946299).
- Information of the 510(k) Cleared Device (Predicate Device):
4. Device Description:
The GM3X3HV is the device which generates twin high voltage pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
5. Intended Use:
The device is an high voltage TENS device with TENS indications used for symptomatic relief and management of chronic intractable pain.
In addition, the standard format for the statement of indications and contraindication for use are provided hereafter.
1
510(K) SUMMARY
6. 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 EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
-
- Conclusions
The high voltage TENS device, model GM3X3HV, has the same intended use and i ne filgh voltage TENS donos, model end device of Skylark PGS123 (K946299). Moreover, technological characteried as the circular this submission demonstrate that the difference in vellifed demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.
- Conclusions
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three horizontal lines extending from its head, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2003
Mr. Boden S.P. Lai General Manager Gemore Technology Co., Ltd. 11FL., No. 29-5, Sec. 2, Chung Cheng E. RD., Tan Shui, Taipei Hsien, Taiwan
Re: K032994
Trade/Device Name: GM3 Series HV TENS Model GM3X3HV Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: September 23, 2003 Received: September 29, 2003
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.
If your device is 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 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); 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.
3
Page 2 - Mr. Boden S.P. Lai
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus. permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours.
Mark N Millasson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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GEMORE TECHNOLOGY CO., LTD.
510(K) SUMMARY
Page of 1
510(k) Number (if known):
Device Name: GEM-HV TENS (Also known as GEM-PGS TENS), High Voltage TENS Device / Model: GM3X3HV, where X is the parameter for different housing with range from 0 to 5.
Indications For Use:
The device is an high voltage TENS device with TENS indications used for symptomatic relief and management of chronic intractable pain.
Prescription Use _ V (Part 21 CFR 801 Subpart D)
AND/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)
Marli N Milkerson
11103-6330 00081 Wision of Coneral, Restorative and Neurological Devices
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