This TENS device is to be used for temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

Device Description

The Counter Pain Therapy Device, Model P.T.S.-IV (K161537) is identical to the previous cleared version of the device with the same name (K132993). The purpose of this 510(k) submission is to seek different (expanded) Indications for Use. The only changes are in the 'Indication for Use Statement'.

The Counter Pain Therapy Device, Model P.T.S.-IV features two channels and seven (7) preset programs. The output of both channels can be adjusted individually for intensity in sixteen (16) steps and the treatment time is selectable from 20, 30 or 40 minutes. All features are well indicated by large icons on a backlit LCD screen for easy reading.

The device is powered by three (3) rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied for the device.

The Pain Therapy Device consists of the handheld main unit (controller), two pairs of self-adhesive electrodes, a plug-in charging unit (adaptor 120VAC to 5VDC) and two pairs of electrode cables.

AI/ML Overview

This document describes the regulatory clearance (K161537) for the OTC TENS Device, Model PTS-IV. However, it explicitly states that no clinical tests were performed or relied upon to determine substantial equivalence for this specific submission because the device itself is identical to a previously cleared version (K132993), and the only change made was an expansion of the Indications for Use. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of clinical performance, cannot be fully provided from this document.

The document primarily focuses on non-clinical testing and substantial equivalence to predicate devices based on design, technological characteristics, and safety standards.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested details are not available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document refers to meeting the requirements of recognized consensus standards for safety and performance. These standards are the acceptance criteria for non-clinical aspects.
Reported Device Performance: The performance is stated in terms of compliance with these standards.

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Safety & Essential Performance: IEC 60601-1:1988 + A1:1991 + A2:1995 "Medical electrical Equipment – Part 1: General requirements for basic safety and essential performance".	Device was tested to and met the requirements in K132993. Non-clinical testing validated the design and assured conformance.
Safety of Nerve and Muscle Stimulators: IEC 60601-2-10: 1987 (first Edition + amendment 1 (2001) for use in conjunction with IEC 60601-1 (1988). Amendments 1 (1991) and 2 (1995) "Medical electrical equipment – Part 2: "Particular Requirements for safety of nerve and muscle stimulators".	Device was tested to and met the requirements in K132993. Non-clinical testing validated the design and assured conformance.
Electromagnetic Compatibility: IEC 60601-1-2: 2001 + A1: 2004 & IEC60601-2-10: 1987 + A1: 2001 Clause 36 Medical Electrical Equipment, Part1-2: "General requirements for Basic Safety and Essential Performance" Collateral Standard: Electromagnetic Compatibility.	Device was tested to and met the requirements in K132993. Performance testing established that, with respect to EMC and electrical safety in its intended operational environment, the device conforms to all applicable requirements.
Biocompatibility: Electrodes are body contacting parts.	Electrodes were tested for biocompatibility as part of their separate FDA 510(k) clearance.
Software Performance: Software performs within specifications and is safe for intended use.	Test results concluded software performs within specifications and is safe. Test protocol sufficiently verifies main functional operation.
Cleaning Effectiveness: Cleaning instructions are sufficient.	Validation of the manual cleaning method as per instructions. Testing concluded the device can be cleaned by the described methods.

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 / Not provided for clinical performance. The document explicitly states: "Counter did not conduct, nor rely upon, clinical tests to determine substantial equivalence of the Pain Therapy Device Model P.T.S.-IV. vs. the predicates."
For non-clinical testing, the "sample size" would refer to the number of devices tested to the standards. This specific number is not provided, only that "testing" was performed. The data provenance would be from internal company testing and third-party lab testing for standards compliance (e.g., electrical safety).

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. No clinical test set with human data and expert-established ground truth was used for this specific 510(k) submission. The regulatory decision was based on substantial equivalence to predicate devices and non-clinical engineering and safety testing.

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

Not applicable. No clinical test set requiring adjudication was used.

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 Transcutaneous Electrical Nerve Stimulator (TENS device), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. The device is a TENS unit, not an algorithm. Its performance is inherent in its electrical output and mechanical operation, as demonstrated by compliance with engineering standards.

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

For the non-clinical tests, the "ground truth" was established by the requirements of the international consensus standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) which define the acceptable limits and performance criteria for safety and electrical characteristics.
For biocompatibility, the ground truth would be chemical/biological analyses demonstrating safety as per relevant biocompatibility standards for medical devices, which were part of the electrode's separate FDA clearance.
For software, the ground truth was the expected functional specifications and safety requirements as defined internally and verified through testing.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that requires a "training set."

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

Not applicable. As above, there is no training set for this type of device.

In summary:

This 510(k) cleared the OTC TENS Device, Model PTS-IV, by demonstrating substantial equivalence to a previously cleared version of the same device (K132993) and to another predicate device (K121757) for its expanded indications for use. The clearance was based entirely on non-clinical testing which confirmed the device's compliance with established safety and performance standards (IEC 60601 series). No clinical studies or human performance data were used for this submission, as the physical device itself had already been vetted in a prior submission, and the current submission only sought to expand its marketing claims (Indications for Use) based on existing equivalence.

Summary

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

October 13, 2016

Counter Scientific Development (GZ) Ltd % Guenter Ginsberg President Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135

Re: K161537

Trade/Device Name: OTC TENS Device, Model PTS-IV Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: September 2, 2016 Received: September 7, 2016

Dear Guenter Ginsberg:

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. 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 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael J. Hoffmann -A

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161537

Device Name OTC TENS Device, Model PTS-IV

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Date of Summary Prepared: 10/12/2016

Submitter's Name: Counter Scientific Development (GZ) Ltd.

2nd & 3rd Floor, Blg. 6, DaPian Industrial Zone Address: Tangxia Road, Tianhe District, Guangzhou, China

Contact person: Wendi Poon, Manager

Tel: +86-20 -8328 9980

Fax: +86-20-38339500

E-mail Counter_csd@yahoo.com.cn

2. Proposed New Device:

Trade Name: OTC TENS Device, Model PTS-IV (K161537)

Manufacturer: Counter Scientific Development (GZ) Ltd.

Classification Name: Transcutaneous electrical nerve stimulator for pain relief Regulation Number: 21 CFR 882.5890 Product Code: NUH Device Class: II

3. Predicate (cleared) Devices:

Primary Predicate: (K132993)

Trade Name: Counter Pain Therapy Device, Model P.T.S.-IV

Counter Scientific Development (GZ) Ltd. Manufacturer:

Secondary Predicate: (K121757)

Trade Name: TENS and Powered Muscle Stimulator, Model Pro-8AB

Manufacturer: Healthmate International, LLC

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4. Description of Proposed Device:

The device is powered by three (3) rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied for the device.

The Pain Therapy Device consists of the handheld main unit (controller), two pairs of self-adhesive electrodes, a plug-in charging unit (adaptor 120VAC to 5VDC) and two pairs of electrode cables.

The device was tested to and met the requirements of the following recognized consensus standards in K132993:

IEC 60601-1:1988 + A1:1991 + A2:1995 "Medical electrical Equipment = Part 1: General requirements for basic safety and essential performance".

IEC 60601-2-10: 1987 (first Edition + amendment 1 (2001) for use in conjunction with IEC 60601-1 (1988). Amendments 1 (1991) and 2 (1995) "Medical electrical equipment -Part 2: "Particular Requirements for safety of nerve and muscle stimulators".

IEC 60601-1-2: 2001 + A1: 2004 & IEC60601-2-10: 1987 + A1: 2001 Clause 36 Medical Electrical Equipment, Part1-2: "General requirements for Basic Safety and Essential Performance" Collateral Standard: Electromagnetic Compatibility.

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5. Indication for Use:

6. Environment of Use:

Clinics, Hospitals and home environments

7. Contraindications:

Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electrical shock, burns, electrical interference, or death.

Do not use this device together with a life-supporting medical electronic device such as an artificial heart or lung.

Do not use this device together with a body-worn medical electronic device such as an ECG.

8. Technological Characteristics Compared to the Predicate Devices

Both Counter Pain Therapy Devices Model P.T.S.-IV, the subject device K161537 and the primary predicate device K132993 are identical in design, technological characteristics and specifications, except for the "Indication For Use" statement. The subject device has expanded "Indications For Use" that are comparable to the secondary predicate device Pro-8AB (K121757). Both have the same intended use and technology. Both, the subject device and the predicate provide electrically generated pulses applied to the skin via electrodes. There are minor technical differences between the two devices.

The electrical stimulation provided by the Counter device is substantially equivalent to that commonly employed by TENS devices that have been cleared for marketing without

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prescription labeling; i.e. for OTC sale. Technological characteristics, features, specifications, materials and intended uses of the subject Counter device are substantially equivalent to the quoted predicate device Pro-8AB. The differences that exist between both of the Counter devices and the predicate device Pro-8AB are insignificant in terms of safety or effectiveness.

9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:

Counter did not conduct, nor rely upon, clinical tests to determine substantial equivalence of the Pain Therapy Device Model P.T.S.-IV. vs. the predicates. Non-clinical testing was performed in the K132993 submission in order to validate the design according to the company's specified design requirements, and to assure conformance with the following voluntary design standards:

IEC 60601-1:1988 + A1:1991 + A2:1995 "Medical electrical Equipment – Part 1: General requirements for basic safety and essential performance".

IEC 60601-2-10: 1987 (first Edition + amendment 1 (2001) for use in conjunction with IEC 60601-1 (1988), Amendments 1 (1991) and 2 (1995) "Medical electrical equipment -Part 2: "Particular Requirements for safety of nerve and muscle stimulators".

a. Biocompatibility

The electrodes are the only body contacting parts. They have been tested for biocompatibility as part of their separate FDA 510(k) clearance.

b. Software

Based upon the test results it was concluded that the software performs within specifications and is safe to the stated intended use. Since a permanent hazard analysis is implemented in the software development process, and due to the clear software architecture, it is believed that the test protocol sufficiently verifies the software's main functional operation.

c. Cleaning

The cleaning instructions as described the Instruction Manual have been tested to be sufficient. Testing involved validation of the manual cleaning method as per the instructions. All testing concluded that that the Pain Therapy Device can be cleaned

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by the use of the methods described in the Instruction Manual.

d. EMC and Electrical Safety

Performance testing in K132993 has established that, with respect to EMC and electrical safety in its intended operational environment, the device conforms to all applicable requirements of IEC 60601-1 and IEC 60601-1-2.

10. Conclusions:

The cleared Counter Pain Therapy Device, Model P.T.S.-IV (K132993) and the subject Counter device (K161537) are identical and only differ in their "Indications for Use" statements . The subject Counter device (K161537) and the secondary predicate Pro-8AB (K121757) by Healthmate Intl, LLC have the same "Indications for Use" and have very similar technical characteristics.

Moreover, bench testing and safety report documentation demonstrate that the submitted device could maintain the same safety and effectiveness as that of predicate device. In the other words, the differences do not affect the intended use and do not raise any new questions of safety or effectiveness or alter the fundamental scientific technology of the device. Thus, the Counter Pain Therapy Devices, Models P.T.S.-IV (K161537) is substantially equivalent to the predicate device Pro-8AB by Healthmate Intl, LLC.

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).