TENS Series Electro-Stimulator, which includes models TENS 2800 and TENS 3000, are Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves through the cable and electrode placed on the skin. The parameters of units are controlled by the rotate buttons. Its intensity level is adjustable according to the needs of patients. These TENS electro-stimulator have the same housing in a molded portable plastic case, an accessible, switch, and accessible battery storage compartment. The case shape is rectangular, The process to set the parameter and attach lead wires to the two models is also the same except the Housing printing artwork, Mode No. TENS 3000 stimulator has three treatment mode: normal mode, burst mode and modulation mode. The treatment mode can by selected by switch. TENS 2800 only one treatment mode: normal mode. The difference on the two device can be identified by panel, Mode No.

AI/ML Overview

The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS device) seeking substantial equivalence to a predicate device. This type of submission does not typically involve clinical trials with acceptance criteria, human readers, or ground truth as would be seen in studies for AI/ML-based diagnostic or prognostic devices. Instead, it focuses on non-clinical engineering and safety performance.

Therefore, many of the requested categories are not applicable to this document. I will fill in the relevant information and indicate where information is not applicable.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (from Predicate Device)	Reported Device Performance (TENS 2800/3000)
Power Source: 9V Battery	9V Battery
Method of Line Current Isolation: Battery Supply N/A	Battery Supply N/A
Patient Leakage Current - Normal Condition: 1.1uA	1.2uA
Patient Leakage Current - Single Fault Condition: 1.3uA	1.3uA
Number of Output Channels: 2	2
Method of Channel Isolation: By enclosure	By enclosure
Regulated Current or Voltage: Voltage control	Voltage control
Software/Firmware/Microprocessor Control: Yes	Yes
Automatic Overload Trip: No	No
Automatic Over Current Trip: No	No
Automatic No Load Trip: No	No
Automatic Shut off: No	No
Patient Override Control: No	No
Indicator Display - On/Off Status: Yes	Yes
Indicator Display - Voltage/Current Level: Yes	Yes
Indicator Display - Low Battery: Yes	Yes
Waveform: Biphasic Rectangular pulse	Biphasic or Monophasic Rectangular pulse
Compliance with Voluntary Standards: IEC60601-1, IEC60601-1-2, IEC60601-2-10	IEC60601-1, IEC60601-1-2, IEC60601-2-10
Compliance with 21 CFR 898: Yes	Yes
Housing Materials & Construction: Enclosure: ABS,94, V-1,80°C,UL Approved	Enclosure: ABS,94, V-1,80°C,UL Approved

Note: Some criteria from the predicate device differ slightly or are not explicitly stated as "acceptance criteria" but serve as a basis for substantial equivalence comparison. For example, timer range, pulse width range, frequency range, weight, and dimensions are compared but aren't presented as strict acceptance criteria in the same way as safety metrics.

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

Not applicable. This is a 510(k) submission for a TENS device, which relies on non-clinical testing (bench testing, safety reports, risk analysis) rather than clinical studies with test sets in the context of diagnostic performance. The document focuses on performance specifications and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth, in the context of expert review, is not relevant for this type of device submission. The "truth" is established by adherence to engineering specifications and safety standards.

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

Not applicable. No expert adjudication method was used, as this was not a clinical evaluation of diagnostic 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 is a TENS device, not an AI-assisted diagnostic or prognostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance 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 hardware-based TENS stimulator, not an algorithm or AI model.

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

The "ground truth" for this submission is based on established electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and performance specifications that are expected for TENS devices, as demonstrated through bench testing and risk analysis. The comparison to the predicate device's characteristics also serves as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. This is an electrical medical device submission, not a machine learning model, so there is no concept of a training set.

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

Not applicable. As there is no training set for a machine learning model, the concept of establishing ground truth for it does not apply.

Summary

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$\qquad 510(k):$

KOALATY PRODUCTS, INC.
A Current Solutions Company

File No: WMI-04-TENS -FDA-05 Version: 1.1

AUG 3 1 2010

510(k) SUMMARY

TENS Electro-Stimulator, K(102014 )

4/15/2010 Date of Submission:

Koalaty Products.,INC 510(k) Submitter's Name:

3814 Woodbury Dr Austin TX 78704 Address:

510(k) Correspondent contact: Kang Jian Ping microcong@gmail.com E-mail: Telephone: +86(755) 27652471 +86(755) 27652674 Fax:

Section 05-Page 1 of 4

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Image /page/1/Picture/0 description: The image shows the logo for KoalaTY Products, INC. The logo features a stylized image of a koala's head on the left. To the right of the koala image, the text "KoalaTY Products, INC." is written in a simple, sans-serif font. Below the company name, the text "A Current Solutions Company" is written in a smaller font.

File No: WMI-04-TENS -FDA-05 Version: 1.0

1. Proposed Device:

Trade Name: TENS 2800 Stimulator TENS 3000 Stimulator Classification Name: Stimulator, Nerve, Transcutaneous. For pain relief Regulation Number: 882.5890 Product Code: GZJ Device Class: ||

2. Predicate Device:

Predicate Device: LT3001 TENS Stimulator 510(k) Number: K100117 Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.

Description of Proposed Device: 3.

These TENS electro-stimulator have the same housing in a molded portable plastic case, an accessible, switch, and accessible battery storage compartment. The case shape is rectangular, The process to set the parameter and attach lead wires to the two models is also the same except the Housing printing artwork, Mode No.

TENS 3000 stimulator has three treatment mode: normal mode, burst mode and modulation mode. The treatment mode can by selected by switch. TENS 2800 only one treatment mode: normal mode. The difference on the two device can be identified by panel, Mode No.

Proposed Device Intended Use Statement: 4.

Device Name:

TENS 2800 Stimulator, TENS 3000 Stimulator

Indications for Use:

Symptomatic relief of chronic intractable pain, 1)
Post traumatic pain 2)
Post surgical pain 3)

Section 05-Page 2 of 4

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KOALATY PRODUCTS, INC.
A Current Solutions Company

File No: WMI-04-TENS -FDA-05 Version: 1.0

5. Biocompatibility Certification:

Electrodes to be provided with this device are from the manufacturer Top-Rank Health Care Equipment Co., Ltd (K070612) who submitted in 2007.

The shell of device is used ABS material; this material has passed Biocompatibility testing in Jiangsu TUV Product Service Ltd. Shanghai Branch. Identification No: 080960.

6. Technological Characteristics and Substantial Equivalence

Both the TENS Series Electro-Stimulator and the Predicate device Stimulator have the same intended use and fundamental technology. A side-by-side comparison of the TENS Series Electro-Stimulator and the cited predicate devices is included in the 510(k) submission. The TENS Series Electro-Stimulator is substantially equivalent to the technological features as the predicate devices.

		New device	Predicate device
1	510K#	K	K100117
2	Device Name	TENS 2800 StimulatorTENS 3000 Stimulator	LT3001 TENS Stimulator
3	Manufacturer	Koalaty Products., INC	Shenzhen DongdixinTechnology Co., Ltd.
4	Power Source	9V Battery	9V Battery
	-Method of Line current isolation	Battery Supply N/A	Battery Supply N/A
	- Patient Leakage Current-Normal condition-Single fault condition	1.2uA1.3uA	1.1uA1.3uA
5	Number of Output Modes	3	6
6	Number of Output Channels	2	2
	Method of channel isolation	By enclosure	By enclosure
7	Regulated Current or regulatedVoltage?	Voltage control	Voltage control
8	Software/Firmware/Microprocessor Control?	Yes	Yes
9	Automatic Overload Trip?	No	No
	Automatic Over Current Trip?	No	No
10	Automatic No Load Trip?	No	No
11	Automatic Shut off?	No	No
12	Patient Override Control?	No	No
13	Indicator Display
	-On/Off Status?	Yes	Yes
	-Voltage/Current Level?	Yes	Yes
	-Low Battery?	Yes	Yes

Basic technological characteristics, new device vs. Predicate device

Section 05-Page 3 of 4

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Image /page/3/Picture/0 description: The image shows the logo for KoalaTY Products, INC. The logo features a stylized image of a koala's head on the left. To the right of the koala image, the text "KoalaTY Products, INC." is written in a bold, sans-serif font. Below the company name, the text "A Current Solutions Company" is written in a smaller, lighter font.

14	Timer Range (minutes)	15min, 30min, continue	30min, 60min, continue
15	Waveform	Biphasic or MonophasicRectangular pulse	Biphasic Rectangular pulse
16	Pulse Width Range	30-260us	50-300us
17	Frequency	2-150Hz	2-120Hz
18	Compliance with Voluntary Standards	IEC60601-1, IEC60601-1-2,IEC60601-2-10	IEC60601-1, IEC60601-1-2,IEC60601-2-10
19	Compliance with 21 CFR 898?	Yes	Yes
20	Weight (grams.)	115 grams(battery included)	128 grams (battery included)
21	Dimensions (mm.) H x W x T	95x65x23.5	102x64x26
22	Housing Materials & Construction	Enclosure: ABS,94, V-1,80°C,UL Approved	Enclosure: ABS,94, V-1,80°C,ULApproved

Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:

TENS Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards:

IEC 60601-1 "Medical electrical equipment Part 1: General requirements for safety". >
IEC 60601-1-2 "Medical electrical equipment Part 1-2: General requirements for safety -A Collateral Standard"
IEC 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of > nerve and muscle stimulators"

Conclusions: 8.

The TENS Series Stimulator, which includes models TENS 2800 and TENS 3000, has the same intended use and technological characteristics as the predicate device. Moreover, bench testing, safety report and Risk Analysis Report documentation supplied in this submission demonstrates that the difference in the submitted models could maintain the same safety and effectiveness as that of predicate device. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device. Thus, the TENS Series Electro-Stimulator is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is smaller than the bird symbol.

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

Koalaty Products, Inc. c/o Mr. Jeffrey D. Rongero Senior Project Engineer, UL Health Sciences Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle, NC 27709

AUG 3 1 2010

Re: K102014

Trade/Device Name: TENS 2800, TENS 3000 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: GZJ Dated: August 11, 2010 Received: August 16, 2010

Dear Mr. Rongero:

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. Ilsting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ucm].15809.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/ReportaProblem/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 yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director

Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KID2014

File No: WMI-04-TENS-FDA-04 Version: 1.1

Indications for Use

AUG 31 2010

510(k) Number ( < 102014 ):

Device Name:

TENS 2800 Stimulator TENS 3000 Stimulator

Indications for Use:

Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Raffi

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K102014

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).