To be used for temporary relief of pain associated with sore and 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 Santamedical Pulse Stimulator, a Transcutaneous Electrical Nerve Stimulator (TENS), is for overthe-counter use and for home use, which is intended to relieve pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities. The portable and microprocessor-controlled Santamedical Pulse Stimulator delivers a gentle electrical pulse through two channels with four attachment pads and shows graphic information about mode style, intensity and time remaining on a LCD based display which is incorporated within the device body.

AI/ML Overview

This is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device, which does not involve AI or complex diagnostic interpretations. Therefore, many of the requested categories concerning AI performance, expert consensus, and ground truth establishment are not applicable.

Here's the analysis based on the provided text:

Device: Santamedical Pulse Stimulator (Transcutaneous Electrical Nerve Stimulator - TENS)

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Specific Criteria	Proposed Device Performance (Met/Not Applicable)
Safety and Electrical	IEC 60601-1 (General basic safety)	Met (Compliance demonstrated through non-clinical tests)
	IEC 60601-1-2 (EMC requirements)	Met (Compliance demonstrated through non-clinical tests)
Electrode Safety	Safety requirements for electrodes	Met (Electrodes meet safety requirements)
Software Verification	FDA Guidance for Software in Medical Devices	Met (Software verification carried out per FDA guidance)
Substantial Equivalence	Demonstration of equivalence to predicate device K122744	Met (Concluded to be substantially equivalent based on comparison)

2. Sample Size Used for the Test Set and the Data Provenance

This is an OTC TENS device. The performance and safety testing described are primarily non-clinical bench testing to confirm compliance with electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2) and electrode safety. Software verification was also performed.

Test Set Sample Size: Not applicable in the context of patient data. The "test set" would refer to the physical device units undergoing non-clinical testing. The document does not specify the number of devices tested, which is typical for such non-clinical regulatory submissions.
Data Provenance: Not applicable in the context of patient data. The data provenance refers to laboratory testing results, not patient or clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth, in the context of this device, refers to the established standards and safety requirements (e.g., electrical parameters, EMC limits). Compliance with these standards is assessed by testing laboratories and engineers, not by clinical experts establishing a "ground truth" for diagnostic or AI performance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for clinical studies involving multiple reviewers for diagnostic agreement or outcome assessment. This submission demonstrates compliance with engineering and safety standards.

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 pain relief stimulator, 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. This device is a physical stimulator, not an algorithm, and does not have standalone AI performance in the way a diagnostic AI would.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" implicitly used for this device is compliance with established electrical safety and electromagnetic compatibility (EMC) standards (IEC 60601-1, IEC 60601-1-2) and FDA's guidance for software in medical devices. The device's technological characteristics were also compared directly to a legally marketed predicate device (K122744).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set for model development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device.

Summary

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K131933

Exhibit 013 Revised 510(k) Summary

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Submitter's Information

Submitter: Gurin Products, LLC Address: 2522 Chambers Road, Suite 100, Tustin, CA 92780 Contact Person: Sanjay Gupta Tel: 888-666-1557 Email: iroams@earthlink.net Date of Preparation: 06/24/2013

2. Proposed Device

Trade Name: Santamedical Pulse Stimulator Common Name: Transcutaneous electrical nerve stimulator Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter (OTC) Regulation Description: Transcutaneous electrical nerve stimulator for pain relief Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: NUH, NGX Regulation Number: 21 CFR 882.5890 Use: Over-The-Counter Device Class: II

3. Predicate device

Prospera OTC TENS Electronic Pulse Massager 510(k) Number: K122744 Submitter: Prospera Corporation

4. Description of Proposed Device

5. Indications for Use

6. Technological Characteristics

Both the proposed and predicate devices have the identical technological characteristics, as shown in Table 1 below.

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	Proposed Device	Predicate Device
510(k) Number	K131933	K122744
Device Name	Santamedical Pulse Stimulator	Prospera OTC TENS ElectronicPulse Massager
Intended Use	To be used for temporary reliefof pain associated with soreand aching muscles in theshoulder, waist, back, neck,upper extremities (arm), andlower extremities (leg) due tostrain from exercise or normalhousehold work activities.	To be used for temporary reliefof pain associated with sore andaching muscles in the shoulder,waist, back, neck, upperextremities (arm), and lowerextremities (leg) due to strainfrom exercise or normalhousehold work activities.
Power Source	Battery	Battery
Number of Output Channels	2	2
Automatic Overload Trip	No	No
Automatic Over Current Trip	No	No
Automatic No-Load Trip	No	No
Automatic Shut Off	Yes	Yes
User Override Control	Yes	Yes
Indicator Display	Yes	Yes
Waveform	Monophasic, pulsed	Monophasic, pulsed
Frequency	1-100 Hz	1-100 Hz
Compliance with VoluntaryStandards	IEC60601-1, IEC60601-1-2	IEC60601-1, IEC60601-1-2
Compliance with 21 CFR 898	Yes	Yes
Housing Materials &Construction	ABS Plastic	ABS Plastic

Tablo 1 Charactoristic com parison hetween the proposed device and predicate device

7. Non-Clinical Tests Performed for Determination of Substantial Equivalence

Compliance to applicable voluntary standards includes IEC 60601-1-2. Non-clinical tests were performed on the proposed Santamedical Pulse Stimulator in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, electromagnetic compatibility, and particular requirements for the safety of nerve and muscle stimulators:

(a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
(b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests".

In addition to the compliance of voluntary standards, the electrodes also meet the safety requirement, and the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

8. Conclusion

The proposed device is substantially equivalent to the predicate device. Therefore, the proposed Santamedical Pulse Stimulator is as safe, as effective, and performs as well as the foregoing identified OTC predicate devices which have been legally marketed in the United States.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.

Public Health Service

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

December 20, 2013

Gurin Products, LLC Sanjay Gupta President 2522 Chambers Road, Suite 100 Tustin, CA 92780

Re: K131933

Trade/Device Name: Santamedical Pulse Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 25, 2013 Received: December 3, 2013

Dear Mr. Gupta:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Sanjay Gupta

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for

Carlos L. Peña, PhD 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): K131933

Device Name: Santamedical Pulse Stimulator

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of

AND/OR

Over-The-Counter Use _ X (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

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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).