(227 days)
Not Found
No
The description details a standard TENS device with preprogrammed modes and adjustable settings, typical of non-AI/ML devices. There is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is described as providing "symptomatic relief and management of chronic intractable pain," which is a therapeutic purpose.
No
This device is a TENS (Transcutaneous Electrical Nerve Stimulation) unit, which is used for symptomatic relief and management of pain. It is a therapeutic device that delivers electrical impulses to nerves, rather than a diagnostic device that identifies or characterizes a medical condition.
No
The device description explicitly states it is a "Transcuntaneus Electrical Nerve Stimulation System" and mentions hardware components like a large LCD panel, battery power, leadwires, and electrodes, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, the TATUNG TMD-26AX SERIES TENS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "symptomatic relief and management of chronic intractable pain." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a Transcutaneous Electrical Nerve Stimulation (TENS) system, which delivers electrical impulses to the body for pain relief. This is a physical therapy modality, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample, which is the defining characteristic of an IVD.
Therefore, the TATUNG TMD-26AX SERIES TENS is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TATUNG TMD-26AX SERIES TENS is intended for symptomatic relief and management of chronic intractable pain.
Product codes
GZJ
Device Description
TATUNG TMD-26AX SERIES TENS Transcuntaneus Electrical Nerve Stimulation System, designed for symptomatic relief and management of chronic intractable pain. It provides a combination of four stimulant modes and good for muscular pain. The device has five preprogrammed function mode, and adjustable output intensity and stimulating rate. With large LCD panel. It is powered by three(3) AAA 1.5V Battery. TATUNG TMD-26AX SERIES TENS requires the use of a set of leadwire and one pair of cutaneous stimulation electrodes.
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
In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included EN 60601-1. EN 60601-1-2 & related FDA Output waveform requirements.
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
ASSECTION Out D
K02179y
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
JAN 1 3 2003
Submitter's Name: Tatung Co. Chungshan N. Rd., 30 Sec., Taipei, Taiwan 104 Address: 22, Tel: 886-2-2592-5252 Ext.2947 886-2-2592-5252 Ext.2492 Fax: Contact: Mr.Ming-Guo Her/General Manager of Taipei Headquarter Plant
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- Device Name
Trade Name: TATUNG TMD-26AX Series TENS , Including Model No. TMD-26AB TATUNG TENS(Blue Case) Model No. TMD-26AY TATUNG TENS(Yellow Case) Model No. TMD-26AW TATUNG TENS(White Case) & any other case color Common Name: TENS unit Classification name: Transcutaneous Electrical Nerve Stimulator
- Device Name
-
- Classification: Class II
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Predicate Device: STIMATE TENS (K003487) marketed by EVERYWAY MEDICAL 4. INSTRUMENTS CO., LTD.
Device Description: TATUNG TMD-26AX SERIES TENS Transcuntaneus Electrical Nerve 5. Stimulation System, designed for symptomatic relief and management of chronic intractable pain. It provides a combination of four stimulant modes and good for muscular pain. The device has five preprogrammed function mode, and adjustable output intensity and stimulating rate. With large LCD panel. It is powered by three(3) AAA 1.5V Battery. TATUNG TMD-26AX SERIES TENS requires the use of a set of leadwire and one pair of cutaneous stimulation electrodes.
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- Intended Use: The TATUNG TMD-26AX SERIES TENS is intended for symptomatic relief and management of chronic intractable pain.
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- Performance Summary: In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included EN 60601-1. EN 60601-1-2 & related FDA Output waveform requirements.
1
Conclusions: 8.
The TATUNG TMD-26AX SERIES TENS have the same intended use and similar technological characteristics as the STIMATE TENS (K003487) marketed by EVERYWAY MEDICAL ^^STRUMENTS CO., LTD. Moreover, bench testing contained in this submission demonstrate that سر differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the TATUNG TMD-26AX SERIES is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread, with the head of the eagle facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2003
Tatung Corporation C/o Ms. Jennifer Reich Harvest Consulting, Incorporated 3892 South America West Trail Flagstaff, AZ 86001
Re: K021794
Trade Name: TATUNG TMD-26AX Series TENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: October 9, 2002 Received: October 10, 2002
Dear Ms. Reich:
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. Iisting 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 - Ms. Jennifer Reich
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 may be obtained 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,
Sincerely yours,
Mark N. Milliman
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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0 (k) NUMBER (IF KNOWN):
DEVICE NAME: TATUNG TMD-26AX Series TENS TATUNG CO.
INDICATIONS FOR USE:
The TATUNG TMD-26AX SERIES TENS is intended for symptomatic relief and management of chronic intractable pain.
Mark N. Milkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021794
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | ||
|---|---|---|
| (Per 21 CFR 801 109) |
OR
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________