T-TECH DIGITAL, MODEL WL-22XXA SERIES by WELL-LIFE HEALTHCARE, INC.

· Relaxation of muscle spasms.
· Prevention or retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education.
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Maintaining or increasing range of motion.

Device Description

The T-tech Digital TENS series, including WL-2202A. WL-2204A. WL-2204A. WL-2204A-P1. WL-2204A-P2, and WL-2205A are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.

T-tech Digital TENS series, models WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.

The stimulation mode for T-tech Digital TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.

AI/ML Overview

The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulation (TENS) device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the new device meets specific, quantitative acceptance criteria through a standalone clinical study.

Therefore, many of the requested elements for an acceptance criteria study, such as sample sizes, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to this 510(k) submission. Instead, the study demonstrating the device meets the "acceptance criteria" here refers to the testing performed to show equivalence to the predicate device and compliance with relevant standards.

Here's the breakdown of the information that can be extracted and a clear indication of what is not present:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence: Device functionality (stimulus generation, output, waveform adjustability, operation modes) is substantially equivalent to the predicate device.	"The T-tech Digital TENS series... have the same intended use and technological characteristics as the cleared device of WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B."
Safety and Effectiveness Equivalence: Differences in the submitted models do not affect safety or effectiveness compared to the predicate device.	"verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."
Compliance with Voluntary Standards: Adherence to relevant electrical safety and biocompatibility standards.	"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."
Software Verification: Software performs as intended and meets regulatory guidelines.	"In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance."

Study Details

Sample sizes used for the test set and the data provenance:
- N/A. This submission is for a TENS device and relies on engineering and performance testing to demonstrate substantial equivalence to a predicate device, not a test set based on patient data in the way an AI/CADe device would. The testing would involve specific units of the device.
- Data Provenance: The document does not specify the origin of any test data beyond the general submission from Well-Life Healthcare Inc. in Taipei, Taiwan. The studies cited are non-clinical (compliance to standards, software verification).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in the context of expert consensus on medical images or diagnoses is not relevant for this type of device submission. The "ground truth" here is the established safety and effectiveness of the predicate device and compliance with engineering standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically associated with expert review of data/images in clinical studies, which is not described here.
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:
- No. An MRMC study is not mentioned. This device is a direct patient-use electrical stimulator, not an AI/CADe device designed to assist human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This device is hardware with embedded software for control, not a standalone AI algorithm. Its performance is inherent to the device's function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this 510(k) submission is established by:
  - Predicate Device Performance: The known performance, safety, and effectiveness of the previously cleared predicate device (K030537: WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B).
  - Voluntary Standards: Established engineering and safety standards (ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-1, EN 60601-1-2).
  - FDA Software Guidance: Best practices for software verification.
The sample size for the training set:
- N/A. There is no mention of a "training set" in the context of machine learning or AI models. This device does not use an AI learning algorithm that requires a training set.
How the ground truth for the training set was established:
- N/A. As no training set is mentioned, this question is not applicable.

Summary

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K033857

DEC 1 9 2003

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: Well-Life Healthcare Inc. Room 6C01, No. 5, Sec. 5, Hsin Yi Rd., Taipei, Taiwan, R.O.C.
  Contact: Ms. Jenny Hsieh Sales Manager

Date of Summary Preparation: December 9, 2003.

1. Name of the Device:
  Well-Life TENS (Transcutaneous Electrical Nerve Stimulation Device), Model T-tech Digital TENS series, including WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A.
1. Information of the 510(k) Cleared Device (Predicate Device): K030537.

4. Device Description:

5. Intended Use:

On the instruction manual of each model, the intended uses and contraindication are defined very clearly. Please see the information of instruction manuals provided this submission document.

In addition, the standard format for the statement of indications and contraindication for use are provided hereafter.

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1. Companson to the 510(k) Cleared Device (Predicate Device):
- (1) The new model WL-2202A and WL-2203A is substantially equivalent to the Well-Life clear model WL-2203B (K030537).
- (2) The new model WL-2204A, 2204A-P1, and 2204A-P2 are substantially equivalent to the Well-Life clear model WL-2204B, WL-2204B-P1, and WL-2204B-P2 (K030537).
- (3) The new model WL-2205A is substantially equivalent to the Well-Life clear model WL-2205B (K030537).
7 . 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 carned out according to the FDA software guidance.

1. Conclusions
  The T-tech Digital TENS series, including WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A, have the same intended use and technological characteristics as the cleared device of WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Jenny Hsiah Well-Life Healthcare, Inc. Room 6C01, No.5, Sec. 5, Hsin Yi Rd. Chung Ching Rd., Pei Tun District Taipei, Taiwan, R.O.C.

Re: K033857

Trade/Device Name: T-tech Digital Models WL-2202A and WL-2203A Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ

Trade/Device Name: 7-tech Digital Models WL-2204A, WL-2204A-P1 and WL-2204A-P2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF

Trade/Device Name: T-tech Digital Model WL-2205A Regulation Number: 21 CFR 882.5890 and 21 CFR 890.5850 Regulation Name: Transcutaneous Electrical Nerve Stimulator and Powered Muscle Stimulator Regulatory Class: Class II Product Code: GZJ and IPF

Dated: Undated Received: December 11, 2003

Dear Ms. Hsiah:

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.

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Page 2 - Ms. Jenny Hsiah

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 (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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours

Sincerely yours,

Mark N. Milliken

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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510(k) Number (if known):_

Device Name: T-tech Digital / Model: WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A.

Indications For Use (Available for WL-2202A, WL-2203A & 'TENS function' of WL-2205A):

This device is a prescription device and only for symptomatic relief of chronic intractable pain.

Indications For Use (Available for WL-2204A, WL-2204A-P1, WL-2204A-P2 & 'EMS function' of WL-2205A):

· Relaxation of muscle spasms.
· Prevention or retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education.
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Maintaining or increasing range of motion.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use √

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Number: K033857

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).