The TENS/IF 14 is a combination TENS and Interferential device which delivers nerve stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device may be powered by either 4 AA batteries or by an AC adapter, that when plugged into a wall outlet provides 6 VDC to the unit. A patient compliance timer can memorize 60 sets of operation records; the total record time is 999 hours.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the TENS/IF 14, focusing on acceptance criteria and the supporting study information:

Summary of Acceptance Criteria and Device Performance:

Acceptance Criteria Category	Reported Device Performance	Comments
Safety Testing	Passed all applicable tests per IEC 60601-1-2.	This is a general compliance statement to an international standard for medical electrical equipment. Specific criteria within this standard are not detailed, but it implies adherence to electrical safety, electromagnetic compatibility, and other general safety requirements.
Electrical Leakage Current	Meets standard requirements.	Specific numerical limits are not provided, but the device confirmed compliance.
Electrode & Lead Wire Safety	Meets standard requirements.	Specific criteria are not provided, but the device confirmed compliance.
Output Current	Meets standard requirements.	Specific numerical limits (e.g., current range, type of current) are not provided, but the device confirmed compliance.
Power Density	Meets standard requirements.	Specific numerical limits are not provided, but the device confirmed compliance.
Technological Characteristics	Output specifications, device design, waveforms, and programmability are substantially equivalent to predicate devices.	This is not an acceptance criterion in the traditional sense of a performance metric, but rather a demonstration of similarity to already-approved devices, which is key for 510(k) clearance.

Study Information Pertaining to Acceptance Criteria:

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set in the context of clinical or performance data. The testing primarily involved engineering performance and safety testing in accordance with IEC 60601-1-2.
- Data Provenance: The standard testing (IEC 60601-1-2) would typically be conducted by the manufacturer or a certified testing laboratory. The document doesn't specify a country of origin for any "data" beyond the manufacturing and submission location. This is not a study involving patient data.
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. This device's clearance is based on engineering and safety performance testing against a recognized standard (IEC 60601-1-2) and demonstration of substantial equivalence to predicate devices, not on a clinical test set requiring expert ground truth for diagnostic accuracy or treatment efficacy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As stated above, this was not a clinical or comparative performance study that would involve expert adjudication of results. The "adjudication" was effectively by the testing laboratory confirming compliance with the technical standard.
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 nerve stimulator, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (nerve stimulator), not an algorithm or software-as-a-medical-device (SaMD). Its performance is inherent in its electrical output and safety, not in an algorithmic assessment.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the safety and performance testing, the "ground truth" was compliance with the technical specifications and safety limits defined by the IEC 60601-1-2 standard. There was no clinical ground truth (like pathology or outcomes data) being established for this type of submission.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.

Summary

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K071869
510(k) Premarket Notification

MAR - 7 2008 Section 5: 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for the Mini Combo 510(k) premarket notification for and in accordance with FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s", June 9, 1999 and "Guidance for Tens 510(k) Content", August 1994.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the TENS/IF 14 is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices .

Sponsor:	EMSI3504 Cragmont Dr. Suite#100Tampa, Florida 33619Ph: 813-471-0129Fax: 813-471-0130Registration Number: 3003573572
Contact:	Cherita JamesM Squared Associates, Inc719 A Street, NEWashington, DC 20002Ph: 202-546-1262 Ext 257Fax: 202-546-3848
Date of submission:	July 3, 2007
Proprietary Name:	TENS/IF 14
Common Name:	Transcutaneous Nerve Stimulator for pain relief, InterferentialCurrent Therapy
Classification Status:	21 CFR 882.5890
Class:	II
Product Code:	GZJ, LIH

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Panel: Neurology

K060246 INFREX by Johari Digital Healthcare, K021755 TENS Predicate Device: TS1211 by Apex Medical, K952683 IF-4000 by Apex Medical

Device Description: The TENS/IF 14 is a combination TENS and Interferential device which delivers nerve stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device may be powered by either 4 AA batteries or by an AC adapter, that when plugged into a wall outlet provides 6 VDC to the unit. A patient compliance timer can memorize 60 sets of operation records; the total record time is 999 hours.

Intended Use: The TENS/IF 14 is intended for use by or on the order of a physician for the symptomatic relief of chronic intractable pain and as an adjunctive treatment for the management of post-traumatic or post-surgical pain.

Discussion of performance testing: Testing performed in accordance with the accepted FDA requirements of IEC 60601-1-2, Medical Electrical Equipment, Part 1: General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility-Requirements and Test, found the TENS/IF 14 passed all of the applicable tests. Based on the output measurements, calculations, and safety testing/inspection; the TENS/IF 14 meets standard requirements with respect to electrical leakage current, electrode and lead wire safety, as well as output current and power density.

Technological Characteristics and Substantial Equivalence

Output specifications, device design, waveforms and programmability demonstrated the TENS/IF 14 to be substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, overlaid with three flowing ribbons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 7 2008

EMSI % M Squared Associates, Inc. Ms. Cherita James 719 A Street, NE Washington, DC 20002

Re: K071869

Trade/Device Name: TENS/IF 14 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ, LIH Dated: January 22, 2008 Received: January 24, 2008

Dear Ms. James:

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.

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

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Page 2 - Ms. Cherita James

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millman

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

Enclosure

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Section 4: Indications for Use Statement

To be assigned 510(k) Number:

TENS/IF 14 Device Name:

Indications for Use:

Symptomatic relief of chronic intractable pain

Adjunctive treatment for the management of post-traumatic or post-surgical pain

AND/OR Over-The-Counter Use Prescription Use (21 CFR 801 Subpart D) (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)

Nishant fn mxm

Division of General, Restorative, and Neurological Devices

510(k) Number K071869

Page 1 of 1

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).