TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING) by TATUNG CO.

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.

AI/ML Overview

The provided 510(k) summary for the TATUNG TMD-26AX Series TENS does not contain specific acceptance criteria or an efficacy study demonstrating its performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device based on similar intended use, technological characteristics, and conformance to general safety and EMC standards.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Specific clinical efficacy endpoint (e.g., pain reduction score)	Not specified. The submission does not include clinical efficacy data.
Safety standards conformance (e.g., electrical safety, electromagnetic compatibility)	Conforms to applicable standards: EN 60601-1 (electrical safety), EN 60601-1-2 (EMC), and "related FDA Output waveform requirements."
Operating specifications (e.g., output intensity, stimulating rate)	"In terms of operating specification," the device conforms to applicable standards. Specific parameters or benchmarks for these specifications are not detailed in the summary.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. There is no mention of a clinical "test set" in the context of an efficacy study. The document refers to "bench testing" but no details on sample size for these tests are provided.
Data Provenance: Not applicable. The submission does not detail any clinical data (either retrospective or prospective) from a specific country of origin related to the device's efficacy. The "bench testing" mentioned is likely in-house laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth establishment by experts for a test set is discussed, as no efficacy study is presented.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS unit), not an AI-powered diagnostic imaging device. Therefore, MRMC studies or AI assistance for human readers are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a TENS unit, not an algorithm. Its operation involves human interaction for placement and setting adjustments, but its "performance" is its ability to deliver electrical stimulation as intended for pain relief. The "bench testing" indirectly assessed its standalone functionality in terms of electrical output and safety.

7. The type of ground truth used

For the "bench testing" related to safety and performance specifications: The ground truth would have been the engineering specifications and regulatory standards themselves (e.g., EN 60601-1, EN 60601-1-2, FDA output waveform requirements). The device's output and performance were compared against these pre-defined technical and safety benchmarks.
For clinical efficacy: Not applicable, as no clinical efficacy study is presented.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of the device's function.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of the K021794 Submission Approach:

The K021794 submission for the TATUNG TMD-26AX Series TENS relies on demonstrating substantial equivalence to a previously cleared predicate device (STIMATE TENS, K003487). This approach primarily involves showing that the new device has:

The same intended use.
Similar technological characteristics.
Any differences in technological characteristics do not raise new questions of safety or effectiveness.

The "bench testing" mentioned serves to support the safety and operational performance in conformance with recognized standards, thereby validating the "similar technological characteristics" claim and addressing any potential safety concerns arising from design differences. It does not involve a prospective clinical study with specific acceptance criteria for clinical efficacy.

Summary

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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

1. 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
1. Classification: Class II
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.

1. Intended Use: The TATUNG TMD-26AX SERIES TENS is intended for symptomatic relief and management of chronic intractable pain.
1. 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.

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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.

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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.

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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,

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)

Over-The-Counter _____________________________________________________________________________________________________________________________________________________________

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).