A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.

AI/ML Overview

The provided document is a 510(k) submission summary for a Transcutaneous Nerve Stimulator (TENS) device. It describes the device, its intended use, and its claim of substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present quantitative acceptance criteria or device performance in the typical sense of a diagnostic or screening algorithm study (e.g., sensitivity, specificity, AUC). Instead, for a TENS device, "acceptance criteria" are related to safety and functionality, and "device performance" refers to demonstrated adherence to these safety and functional standards, and equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety	Tested in accordance with applicable standards for medical device electrical safety.
Electromagnetic Compatibility (EMC)	Tested in accordance with applicable standards for electromagnetic compatibility.
Safety of Nerve and Muscle Stimulators (Specific Requirements)	Tested in accordance with particular requirements for safety of nerve and muscle stimulators.
Accessory Safety (Electrodes)	Specified 510(k) electrodes are used and meet safety requirements.
Accessory Safety (Patient Cable)	Patient cable utilizes shrouded connectors to meet lead wire safety requirements.
System Level Functionality (Waveform Testing)	System level testing, including waveform testing, was performed.
Substantial Equivalence (to Predicate Devices)	New devices (EVERLIFE Transcutaneous Nerve Stimulators) are found to be as safe and effective as, and function in a manner equivalent to, the predicate devices based on product description and tests. Specifically, several models are either "Identical" or demonstrate "Substantial Equivalence" to predicate devices (K902102, K931570, K012643, K021755, K970429).

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

This document describes a device used for pain relief, not a diagnostic or screening algorithm that would typically have a "test set" of patient data. The evaluation primarily relies on bench testing for electrical safety and functional equivalence, rather than clinical data from a "test set" of patients.

Sample Size for Test Set: Not applicable in the context of this submission. The tests performed are on the device itself and its accessories, not a dataset of patient cases.
Data Provenance: The device manufacturer (EVERLIFE MEDICAL EQUIPMENT CO., LTD.) is based in HSIN-CHU CITY, CHINA (TAIWAN). The testing described is non-clinical bench testing.

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

Not applicable. The submission focuses on non-clinical testing and comparison to predicate devices, not on diagnostic accuracy against a "ground truth" established by experts.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication of test set results is mentioned, as the evaluation is based on objective engineering and safety standards.

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

No. This document explicitly states: "Clinical Tests Submitted: None". Therefore, no MRMC study comparing human readers with and without AI assistance was conducted or reported.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical device (TENS unit), not an AI algorithm. Its performance is inherent in its electrical and mechanical functions, not a standalone algorithmic output.

7. Type of Ground Truth Used

The "ground truth" in this context is the fulfillment of established engineering and safety standards for TENS devices, and the demonstrated functional equivalence to legally marketed predicate devices. There is no "ground truth" derived from patient pathology, outcomes, or expert consensus in a clinical sense for this 510(k) submission.

8. 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" of data.

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

Not applicable, as there is no training set mentioned in this submission.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS for Transcutaneous Nerve Stimulator

510(k) No: K071624

DATE OFSUBMISSION:	June 1, 2007
SUBMITTER:	EVERLIFE MEDICAL EQUIPMENT CO., LTD.NO 58, FU-CHIUN ST.HSIN-CHU CITY, CHINA (TAIWAN) 30067TEL: 886-3-5208829FAX:886-3-5209783
ESTABLISHMENTREGISTRATION NO:	3004753827	NOV 27 2007
OFFICIALCONTACT:	Dr. JEN, KE-MINNO 58, FU-CHIUN ST.HSIN-CHU CITY, CHINA (TAIWAN) 30067TEL: 886-3-5208829FAX:886-3-5209783
TRADE NAME:	EVERLIFE Transcutaneous Nerve Stimulator,T-100201, T-100202, T-100203, T-100801,T-100802, T-100803, T-100501, T100502,SD-100506,T-201110, T-201210, T-201310, T-300708
COMMON/USUALNAME:	Transcutaneous Nerve Stimulator
CLASSIFICATIONNAME:	Transcutaneous Nerve Stimulator
REGULATIONNUMBER:	882.5890, GZJ, Class II
PREDICATEDDEVICE:	APEX Transcutaneous Nerve Stimulator,K902102, K931570, K012643, K021755, K970429,( Please refer to the following comparison page.)
INTENDED USE:	To be used in symptomatic relief of chronic intractablepain, post-traumatic and post surgical pain

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Comparison for Predicate Device & Subject Device

510KNumber	APEX Model(predicate device)	Everlife Model(new device)	Note
K902102	COM-TENS	T-100201	Identical
		T-100202	Substantial Equivalence
		T-100501	Substantial Equivalence
		T-100502	Substantial Equivalence
		T-100801	Substantial Equivalence
		T100802	Substantial Equivalence
K931570	COM-TENS(Single Mode)	T-100203	Identical
		T-100803	Substantial Equivalence
K012643	Apex MedicalLCD TENS-VII	T-300708	Identical
K021755	TS-1211	T-201110	Identical
	TS-1211	T-201310	Substantial Equivalence
K021755	TS-1212	T-201210	Identical
K970429	BIOSCOPESD TENS	SD-100506	Identical

、

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Description of Device:	A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.
Non-Clinical Tests Submitted:	The EVERLIFE Transcutaneous Nerve Stimulator has been tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, and the particular requirements for safety of nerve and muscle stimulators. Accessories also meet safety requirements: 510(k) electrodes are specified, and the patient cable utilizes shrouded connectors to meet lead wire safety requirements. System level testing including waveform testing was performed in combination the EVERLIFE Transcutaneous Nerve Stimulator.
Clinical Tests Submitted:	None
Conclusion:	As the product description and tests as above, the new device: EVERLIFE Transcutaneous Nerve Stimulators are as safe and effective as, and the function in a manner equivalent to the predicate devices. Thus the new device is substantially equivalent to the predicate devices in this aspect.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

NOV 2 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Everlife Medical Equipment Co., Ltd. % Dr. Jen Ke-Min No. 58, Fu Chiun Street I Isin Chu City, 30067 Taiwan, ROC

Re: K071624

Trade/Device Name: Everlife Transcutaneous Nerve Stimulator models T-100201, T-100202, T-100501, T-100502, T-100801, T-100802, T-100203, T-100803, T-300708, T-201110, T-201310, T-201210, SD-100506 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: October 29, 2007 Received: November 6, 2007

Dear Dr. Jen Ke-Min:

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.

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Page 2 – Dr. Jen Ke-Min

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ought mating of substantial equivalence of your device to a legally prematics notification: "The PDF Interessification 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 11 you active epper for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (240) 276 0126. Fire Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems (Nedical Donoc Reporting (112)); per general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
Director

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:	K071624
----------------	---------

Device Name:

EVERLIFE Transcutaneous Nerve Stimulator, T-100201, T-100202, T-100203, J T-100801, T-100802, T-100803, T-100501, T100502, SD-100506, T-201110, T-201210, T-201310, T-300708

Indications for Use :

To be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

Prescription Use V

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

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

510(k) Num

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).