Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard TENS device with adjustable amplitude and fixed parameters (pulse rate, frequency, timer). There is no mention of adaptive algorithms, learning capabilities, or any terms associated with AI/ML. The device's operation is described as a simplification of a predicate device's burst mode, further indicating a lack of advanced computational features.

Therapeutic

Yes
The device is described as being "intended for symptomatic relief of chronic intractable pain" and "used for pain relief," which clearly indicates a therapeutic purpose.

Diagnostic

No
The device is described as a "transcutaneous electrical nerve stimulator used for pain relief." Its intended use is "for symptomatic relief of chronic intractable pain," which indicates a therapeutic rather than a diagnostic purpose. It applies an electrical current for treatment, not for identifying a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Mini-TENS series consists of a stimulus generator and electrodes, which are hardware components used to deliver electrical current to the patient.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "symptomatic relief of chronic intractable pain." This describes a therapeutic application, not a diagnostic one.
Device Description: The device is a transcutaneous electrical nerve stimulator (TENS) that applies electrical current to the skin for pain relief. This is a physical therapy modality, not a method for analyzing biological samples.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on the analysis of samples.
- Reagents, calibrators, or controls used in laboratory testing.

In summary, the Mini-TENS is a therapeutic device used for pain management, not a diagnostic device used for analyzing biological samples to provide information about a patient's health.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Mini-TENS including a series of TENS models (WL-2401, WL-2402, WL-2403, and WL-2302) is intended for symptomatic relief of chronic intractable pain.

Product codes (comma separated list FDA assigned to the subject device)

GZJ

Device Description

The Mini-TENS series, including WL-2401, WL-2402, WL-2403, and WL-2302 are transcutaneous electrical nerve stimulator used for pain relief 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.

Mini-TENS series, models WL-2401, WL-2402, WL-2403, and WL-2302, 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 Mini-TENS is burst mode with fixed pulse rate, frequency, and fixed timer. Only amplitude is adjustable. This operation way is considered the simplification from the burst mode of comparison clear model, WL-2102A. Every model of Mini-TENS has its individual stimulation operation cycle.

The Mini-TENS series (WL-2401, WL-2402, WL-2403, and WL-2302) are almost identical in function outlook and specification. The main differences between these four models are indicated in the following table.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K002874

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

Image /page/0/Picture/1 description: The image shows the word "ANNEX" followed by the Roman numeral "II", all enclosed in a rectangular box. The text is in a bold, sans-serif font and appears to be a title or heading. The black ink of the text contrasts with the white background, making it easily readable.

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: _K020020

DEC 3 0 2002

Submitter's Identifications: Well-Life Healthcare Inc. Room 6C01, No. 5, Sec. 5, Hsin Yi Rd., Taipei, Taiwan, R.O.C.

Contact: Ms. Grace Chang Sales Manager

Date of Summary Preparation: October, 2001.

1. Name of the Device: Well-Life TENS (Transcutaneous Electrical Nerve Stimulation Device), Model Mini-TENS series. including WL-2401, WL-2402, WL-2403, and WL-2302.
1. Information of the 510(k) Cleared Device (Predicate Device):

4. Device Description:

The Mini-TENS series, including WL-2401, WL-2402, WL-2403, and WL-2302 are transcutaneous electrical nerve stimulator used for pain relief 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.

Mini-TENS series, models WL-2401, WL-2402, WL-2403, and WL-2302, 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 Mini-TENS is burst mode with fixed pulse rate, frequency, and fixed timer. Only amplitude is adjustable. This operation way is considered the simplification from the burst mode of comparison clear model, WL-2102A. Every model of Mini-TENS has its individual stimulation operation cycle.

The Mini-TENS series (WL-2401, WL-2402, WL-2403, and WL-2302) are almost identical in function outlook and specification. The main differences between these four models are indicated in the following table.

1

| Model | Outlook | Time for
each
operation
cycle | Combination of
wave form | Wave form information | | | |
|----------------------|---------|----------------------------------------|--------------------------------------------------------------------------|-----------------------|----------------------|------------------------|------------------|
| | | | | Type | Pulse rate
(Hz) | Pulse width
(μs) | Time
duration |
| Mini-TENS
WL-2401 | Type A | 60
minutes | Single wave
form (A) | A | 30 | 250 | 3s/ON,
5s/OFF |
| Mini-TENS
WL-2402 | Type B | 15
minutes | A/1min→
B/1min→
C/1min, repeat 5
times | A | 3060
auto-change | 250 | 6s/ON,
1s/OFF |
| | | | | B | 30 | 150250
auto change | 6s/ON,
1s/OFF |
| | | | | C | 3060
auto change | 150250
auto change | 6s/ON,
1s/OFF |
| Mini-TENS
WL-2403 | Type C | 30
minutes | Single wave
form (A) | A | 25 | 115 | 4s/ON,
1s/OFF |
| Mini-TENS
WL-2302 | Type C | 15
minutes | A/2min→
B/2min→
C/2min→
B/2min→
D/2min→
B/2min→
C/3min | A | 2 | 115 | 2s/ON,
1s/OFF |
| | | | | B | 30 | 115 | 2s/ON,
1s/OFF |
| | | | | C | 4 | 115 | ON |
| | | | | D | 15 | 115 | 4s/ON,
1s/OFF |

The WL-2402 is the most complicate in these three models, so the assessment results for the features of performance and safety of this model could cover that of the other three models.

While comparing with the original 510(k) clear device, WL-2102A. The main difference between burst mode operation of WL-2102A and Mini-TENS are indicated as the following table:

| Comparison

features	Clear model	New models
	WL-2102A	WL-2401	WL-2402	WL-2403	WL-2302
Timer control	15/30/60 mins
adjustable	60 mins fixed	15 mins fixed	30 mins fixed	15 mins fixed
Burst duration
time	0.1s/ON,
0.4s/OFF	3s/ON, 5s/OFF	6s/ON, 1s/OFF	4s/ON, 1s/OFF	2s/ON, 1s/OFF
or 4s/ON,
1s/OFF or
always ON
Pulse rate
(Hz)	100Hz fixed	30Hz fixed	30~60Hz auto
change	25Hz fixed	2/4/15/30 Hz
auto change
Pulse width
(μs)	0~260μs
adjustable	250μs fixed	150~250μs
auto change	115μs fixed	115μs fixed
Amplitude
(mA)	0~80mA
adjustable	0~50mA
adjustable	0~50mA
adjustable	0~50mA
adjustable	0~50mA
adjustable
Combination
for the type of
wave form	Single (A)	Single (A)	3 wave forms
combination:
A(1m)→B(1m)→C(1m), 5
repeat	Single (A)	4 wave forms
combination:
A(2m)→B(2m)→
C(2m)→B(2m)→
D(2m)→B(2m)→
C(3m)

2

ANNEX II

5. Intended Use:

Mini-TENS series including WL-2401, WL-2402, WL-2403, and WL-2302, is a portable, batterypowered, transcutaneous electrical nerve stimulators (TENS device) that are used in the treatment of pain syndromes, that is intended for use on intact skin, and that do not require surgical intervention or violation of the skin surface.

The electrode is included in the packing of Mini-TENS series.

Because that all the performances tested are completely within the limit of standard, and all the labeling is provided according to the requirement of standard, the Well-TENS series fall completely within the scope of clause 1 of ANSI/AAMI NS4-1985.

6. Comparison to the 510(k) Cleared Device (Predicate Device):

Features	Clear model	New model
	WL-2102A	WL-2401	WL-2402	WL-2403	WL-2302
1. 510(k) Number	K002874	K020020	K020020	K020020	K020020
2. Device Name, Model	Well-TENS,
WL-2102A	Mini-TENS,
WL-2401	Mini-TENS,
WL-2402	Mini-TENS,
WL-2403	Mini-TENS,
WL-2302
3. Manufacturer	Well-Life	Well-Life	Well-Life	Well-Life	Well-Life
4. Power Source(s)

Method of Line Current
Isolation | 1x9V Alkaline
Type BF | 1x3V Lithium
Type BF | 1x3V Lithium
Type BF | 1x3V Lithium
Type BF | 1x3V Lithium
Type BF | |
| Normal condition
Single fault condition |