WELL-LIFE OTC EMS SYSTEM by WELL-LIFE HEALTHCARE LIMITED

The Well-Life OTC EMS System / model no. WL-2412(A) is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

Device Description

The Well Life OTC EMS System, model no. WL-2412(A) is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance; it is not intended as a therapy for any medical condition. Basically the model WL-2412(A), powered by 4.5V (3xAAA/Alkaline battery), is muscle stimulation device and identical to the SE predicate device - Slendertone EnerVive, Type 561, vith the following features:

<1> It is a portable two-channel, battery operated neuromuscular electronic stimulation system.
<2> It contains 6 programs as the predicate device; the output waveform is selectable pre-programming change among P1~P6
<3>The output strength is adjustable at 0~~80mA via requlated voltage, with variable setting time 5~~60 minutes counting from switching ON.
<4>The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication.
<5> The device uses exactly Ultrastim Electrode (K000947) same as predicate device, providing as stimulation transmission media.

AI/ML Overview

The provided text describes a 510(k) summary for the Well-Life OTC EMS System, model WL-2412(A). It establishes substantial equivalence to a predicate device, the Slendertone EnerVive 561 (K071666). The approval process for this device did not involve typical "acceptance criteria" and a "study proving the device meets the acceptance criteria" in the way a diagnostic or treatment algorithm would. Instead, the focus is on demonstrating that the new device has "the same safety and effectiveness" as a legally marketed predicate device through technical comparison and compliance with standards.

Here's a breakdown based on the information provided and what can be inferred for a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission, the "acceptance criteria" and "reported device performance" are primarily based on the comparison to the predicate device and adherence to established standards. There aren't specific numerical performance metrics in the way a diagnostic algorithm (e.g., sensitivity, specificity) would have. The criteria are related to maintaining fundamental technological characteristics and safety/effectiveness.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Well-Life OTC EMS System WL-2412(A))
Intended Use Equivalence: Same intended use as predicate.	"The Well-Life OTC EMS System / model no. WL-2412(A) is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance," which is the same as the predicate.
Technological Characteristics Equivalence: Similar fundamental technological characteristics to predicate.	See detailed comparison table below. Minor differences in voltage and current at specific resistances are within acceptable deviation ranges (±20%).
Safety and Effectiveness Equivalence: No new safety or effectiveness concerns.	The submission states that "the WL-2412(A) could maintain the same safety and effectiveness as that of cleared device."
Compliance to Applicable Standards: Adherence to relevant voluntary standards.	Compliance to ANSI/AAMI NS4-1985, EN 60601-1, and EN 60601-1-2. Software verification carried out according to FDA guidance.

Detailed Comparison of Technological Characteristics (from text):

Attribute	Predicate Device (EnerVive 561, K071666)	Well-Life OTC System (WL-2412(A))	Discussion of Difference (implicitly accepted if "Same" or within tolerance)
Design	Muscle Stimulator	Muscle Stimulator	Same
Size	104×63.4×30 mm	90×52.5×18.9 mm	(No specific acceptance criteria listed for size, considered non-critical)
Waveform	Symmetrical biphasic square	Symmetrical biphasic square	Same
Channels	Dual	Dual	Same
Power supply	9V	4.5V	Same (likely referring to the function of power supply, not voltage)
Material (Unit Housing)	ABS plastic	ABS plastic	Same
Number of Self-Adhesive Electrodes	2 pairs of butterfly gel pads type 719	2 pairs of ULB 355	Same supplier; 510(k) K000947 cleared
Nos. of Programs	6	6	Same
Amplitude (mA)	0~80	0~80	Same
Pulse rate (Hz)	4~99	4~99	Same
Pulse width (µS)	200~300 (also listed below as 200-300)	200~300	Same
Frequency (Hz)	4-99	4-99	Same
Maximum Phase charge (µC) @500Ω	28.4	28.4	Same
Maximum Current Density (mA/cm²) @500Ω	0.1485	0.1485	Same
Maximum Power Density (W/cm²) @500Ω	0.00594	0.00594	Same
RMS Voltage (RMSV) (±20%) @ 500Ω	7.5V	8.8 V	Max. deviation 17.3%, within acceptabledeviation range (±20%).
RMS Voltage (RMSV) (±20%) @ 1KΩ	12.5V	11.7V	Within acceptable deviation range (9.6%)
RMS Voltage (RMSV) (±20%) @ 1.5KΩ	13.7V	13.8V	Within acceptable deviation range (1.1%)
RMS Voltage (RMSV) (±20%) @ 2kΩ	-	16.3V	(New point for WL-2412A)
RMS Voltage (RMSV) (±20%) @ 10kΩ	-	27.2V	(New point for WL-2412A)
RMS Current (RMSA) (±20%) @ 500Ω	15mA	17.6mA	Within acceptable deviation range (17.3%, derived from voltage deviation)
RMS Current (RMSA) (±20%) @ 1KΩ	12.5mA	11.7mA	Within acceptable deviation range (9.6%)
RMS Current (RMSA) (±20%) @ 1.5kΩ	9.1mA	9.2mA	Within acceptable deviation range (1.1%)
RMS Current (RMSA) (±20%) @ 2kΩ	-	8.15mA	(New point for WL-2412A)
RMS Current (RMSA) (±20%) @ 10kΩ	-	2.72mA	(New point for WL-2412A)
Prescription or OTC	OTC	OTC	Same

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on non-clinical tests (comparison of specifications and compliance with standards) rather than clinical studies with patient test sets. Therefore, there is no sample size for a test set in the traditional sense of patient data. The "testing" involved verifying the new device's specifications against those of the predicate and against engineering standards. The data provenance is from the device manufacturer (Well Life Healthcare Limited in Taiwan) and relates to their internal testing and comparison. The nature of these tests is not explicitly stated as retrospective or prospective in the context of patient data, as it's primarily engineering verification.

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

Not applicable. As noted above, there isn't a "test set" of patient data requiring expert ground truth in this 510(k) submission. The ground truth for this submission is based on engineering specifications and adherence to recognized standards for electrical medical devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no adjudicated test set of clinical data.

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 muscle stimulator, not an AI-powered diagnostic or interpretation tool that would involve human readers.

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

Not applicable. This is a hardware medical device with pre-programmed settings, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission is the engineering specifications of the predicate device and the new device, along with established international and national standards (e.g., ANSI/AAMI NS4-1985, EN 60601-1, and EN 60601-1-2) for the safety and performance of powered muscle stimulators. The verification and validation tests confirmed that the WL-2412(A) met the technical requirements and maintained safety and effectiveness comparable to the predicate.

8. The sample size for the training set

Not applicable. This being a hardware muscle stimulator, there is no "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the title of a document, which is a 510(K) Summary. The text "well life" is shown above the title, along with a butterfly image. The text "Page 1 of 4" is shown below the title.

JUL - 1 2011

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: K102786

1. Submitter's Identifications: Well Life Healthcare Limited 1F., No. 16, Lane 454, Jungjeng Road, Yunghe City, Taipei County 234, Taiwan, ROC
  Contact: Jenny Hsieh Telephone: + 886 2 2928 2112

Date of Summary Preparation: May 25,2011

1. Name of the Device:
  Trade Name : Well-Life OTC EMS Systems / Model : WL-2412(A) Common Name : Powered Muscle Stimulator, OTC Classification Name: Stimulator, muscle, Powered, for muscle conditioning Product Code : NGX Regulation Class : II Regulation Number : 890,5850
1. Information of the 510(k) Cleared Device (Predicate Device): 1> Slendertone EnerVive, Type 561- muscle stimulator ( K071666) 2> Ultrastim Electrode - K000947

4. Device Description:

Basically the model WL-2412(A), powered by 4.5V (3xAAA/Alkaline battery), is muscle stimulation device and identical to the SE predicate device - Slendertone EnerVive , Type 561, vith the following features:

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Image /page/1/Picture/0 description: The image shows the text "510(K) Summary Page 2 of 4". Above the text is a logo that says "wetlife" with a butterfly image. The text is underlined.

<1> It is a portable two-channel, battery operated neuromuscular electronic stimulation system.
<2> It contains 6 programs as the predicate device; the output waveform is selectable pre-programming change among P1~P6
<3>The output strength is adjustable at 0~~80mA via requlated voltage, with variable setting time 5~~60 minutes counting from switching ON.
<4>The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication.
<5> The device uses exactly Ultrastim Electrode (K000947) same as predicate device , providing as stimulation transmission media.
1. Intended Use:

The Well-Life OTC EMS System / model no. WL-2412(A) is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance .

1. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
  Compliance to applicable voluntary standards includes ANSI/AAM, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement.

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software quidance.

7. Conclusions

The Well-Life OTC EMS System / model no. WL-2412 (A) , by applying the same stimulus parameters and used with same type of stimulation transmission media by Ultrastim Electrode (K000947), has the same intended use as the cleared device- Slendertone EnerVive 561( K071666).

A summary of the technological characteristics of WL-2412(A) side-by side comparison to the predicate device is given below :

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510(K) Summary Page 3 of 4

		SLENDERTONE	Well-Life OTC System,
Attribute		EnerVive 561	WL-2412(A)(this submission)	Discussion of Difference
		510(k)K071666
Design		Muscle Stimulator	Muscle Stimulator	same
		Size: 104×63.4×30 mm	Size: 90×52.5×18.9 mm
Waveform		Symmetrical biphasicsquare	Symmetrical biphasicsquare	Same
Channels		Dual	Dual	Same
Power supply		9V	4.5V	same
Material		Unit Housing -ABS	Unit Housing -ABS	same
		plastic	plastic
Number of Self-Adhesive Electrodes		2 pairs of butterflygel pads type 719	2 pairs of ULB 355	Same supplier510(k) 000947 cleared

Nos. of Programs		6	6	Same
Amplitude (mA)		0~80	0~80	Same
Pulse rate (Hz)		4~99	4~99	Same
Pulse width (µS)		200~300	200~300	Same
Power ON indicator		LCD	LCD	Same
Pulse Width (µS)		200-300	200~300	Same
Frequency (Hz)		4-99	4-99	Same
Maximum Phase charge (µC)@500Ω		28.4	28.4	Same
Maximum Current Density (mA/cm²)@500Ω		0.1485	0.1485	Same
Maximum Power Density (W/cm²)@500Ω		0.00594	0.00594	Same
RMS Voltage (RMSV) (±20%)	@ 500Ω	7.5V	8.8 V	The max. deviation betweenWL-2412(A) and K071666 is17.3%, within the acceptabledeviation range ((±20%).Deviation 17% at @ 500Ω ,Deviation 9.6% at @ 1kΩ*Deviation 1.1% at @ 1.5 kΩ
	@ 1KΩ	12.5V	11.7V
	@ 1.5KΩ	13.7V	13.8V
	@ 2kΩ	-	16.3V
	@ 10kΩ	-	27.2V
RMS Current (RMSA)(±20%),	@ 500Ω	15mA	17.6mA
	@ 1KΩ	12.5mA	11.7mA
	@ 1.5kΩ	9.1mA	9.2mA
	@ 2kΩ	-	8.15mA
	@ 10kΩ	-	2.72mA
Prescription or OTC		OTC	OTC	Same

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Image /page/3/Picture/0 description: The image shows the end of a document, specifically page 4 of 4, which is a 510(K) summary. At the top of the page is a logo that appears to be a butterfly with the word "wellife" written across the wings. The text "510(K) Summary" is written in a large font, and the page number is written below it.

The verification and validation tests contained in this submission demonstrate that the WL-2412(A) could maintain the same safety and effectiveness as that of cleared device.

ﺳ ﺳﮯ ﺳ

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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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Well-Life Healthcare, Limited % Ms. Jenny Hsieh 1F1., No. 16, Lane 454, Jungjeng Road Yunghe City, Tiapei County China (Taiwan) 234

JUL - 1 2011

Re: K102786

Trade/Device Name: Well-Life OTC EMS System/Model WL-2412(A) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 30, 2011 Received: June 30, 2011

Dear Ms. Hsieh:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Jenny Hsieh

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor-You/Industry/default.htm.

Sincerely vours.

E. Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known): K102786

Device Name: Well-Life OTC EMS System / Model : WL-2412(A)

Indications For Use:

The Well-Life OTC EMS System / model no. WL-2412(A) is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance .

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (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 Surgical, Orthopedic, and Restorative Devices

5.10(k) Number K102786

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).