TENS-EMS-14

• K Number: K083030
• Device Name: TENS-EMS-14
• Manufacturer: EMSI
• Date Cleared: 2009-02-05 ( 118 days)
• Product Code: GZJ , IPF
• Regulation Number: 882.5890
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: K140467

Intended Use

TENS- Transcutaneous Nerve Stimulation

• . Symptomatic relief of chronic intractable pain
• Post traumatic and post surgical pain relief .

EMS- Electrical Muscle Stimulation

• . Relaxation of muscle spasm
• . Increasing local blood circulation
• . Muscle re-education
• . Prevention or retardation of disuse atrophy
• . Prevention of venous thrombosis of the calf muscles immediately after surgery
• . Maintaining or increase range of motion

Device Description

The TENS-EMS-14 is a combination TENS and EMS device which delivers nerve or muscle 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 is powered by 4 AA batteries. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.

AI/ML Overview

This document is a 510(k) premarket notification for the EMSI TENS-EMS-14, a combination Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle Stimulation (EMS) device. The purpose of this notification is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a de novo study with acceptance criteria and performance data in the typical sense of a medical diagnostic or AI-powered device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen for devices that require extensive performance validation (e.g., diagnostic accuracy for AI algorithms).

Here's a breakdown of why the requested information is absent and what the document does discuss:

1. A table of acceptance criteria and the reported device performance: This is not present. The document focuses on demonstrating substantial equivalence to predicate devices, which means showing that its technological characteristics, intended use, and safety/effectiveness are similar to devices already cleared by the FDA. The "Discussion of performance testing" section mentions general safety testing (electrical leakage current, electrodes, leads, output current, power density) in accordance with IEC 60601-1-2, but does not provide specific acceptance criteria or quantitative performance results for each.

2. Sample size used for the test set and the data provenance: Not applicable/not provided. This type of information is relevant for studies involving data analysis (e.g., image analysis, diagnostic algorithms), which is not the nature of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.

4. Adjudication method for the test set: Not applicable/not provided.

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 TENS/EMS stimulator, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not provided in the context of device performance. The "ground truth" here would relate to the physical and electrical safety standards it passed.

8. The sample size for the training set: Not applicable/not provided.

9. How the ground truth for the training set was established: Not applicable/not provided.

Summary of what the document does provide:

• Intended Use: Details the specific medical conditions for which the TENS and EMS functions are intended.
• Safety Testing: Mentions that safety testing was performed in accordance with IEC 60601-1-2 (Medical Electrical Equipment, Part 1: General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility- Requirements and Test), and the device "passed all of the applicable test." However, no specific pass/fail criteria or quantitative results are elaborated.
• Substantial Equivalence: States that the device's output specifications, design, waveforms, and programmability demonstrated it to be substantially equivalent to a predicate device. This is the primary "proof" in a 510(k) submission for this type of device.

In conclusion, the 510(k) summary for the EMSI TENS-EMS-14 does not include the detailed performance study information with explicit acceptance criteria, sample sizes, and ground truth establishment methods that would be pertinent to a device requiring such validation, especially one involving AI or diagnostic interpretation. Instead, it relies on demonstrating adherence to general safety standards and substantial equivalence to a predicate device already on the market.

Summary

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EMSI TENS-EMS-14

510(k) Premarket Notification

Section 5: 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for the TENS-EMS-14 510(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" Draft 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-EMS-14 is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.

• Applicant:
  EMSI 3504 Cragmont Dr. Suite#100 Tampa, Florida 33619 Ph: 813-471-0129 Fax: [phone] Registration Number: 3003573572

Contact:

use.

Cherita James M Squared Associates, Inc 901 King Street, Suite 200 Alexandria, Virginia 22314 Phone: [phone] Ext. 257 Facsimile: 703-562-9797

Date of submission:	April 4, 2008
Proprietary Name:	TENS-EMS-14
Common Name:	Powered Muscle Stimulator, Transcutaneous Nerve Stimulator
Classification Status:	21 CFR 890.5850, 21 CFR 890.5890
Product Code:	IPF, GZJ
Panel:	Physical Medicine, Neurology
Predicate Device:	EMSI's TENS-EMS-14 is substantially equivalent, for the purpose of this 510(k), to other devices that have received 510(k) clearance for similar indications for

FEB -5 2009

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Device Description: The TENS-EMS-14 is a combination TENS and EMS device which delivers nerve or muscle 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 is powered by 4 AA batteries. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.

Intended Use: As prescribed by a physician for the following:

TENS- Transcutaneous Nerve Stimulation

• . Symptomatic relief of chronic intractable pain
• Post traumatic and post surgical pain relief .

EMS- Electrical Muscle Stimulation

• . Relaxation of muscle spasm
• . Increasing local blood circulation
• . Muscle re-education
• . Prevention or retardation of disuse atrophy
• . Prevention of venous thrombosis of the calf muscles immediately after surgery
• . Maintaining or increase range of motion

Discussion of performance testing: Based on the output measurements, calculations, and safety testing/inspection; the TENS-EMS-14 is safe with respect to electrical leakage current, electrode and lead wire safety, as well as output current and power density. 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-EMS-14 passed all of the applicable test.

Technological Characteristics and Substantial Equivalence

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

FEB - 5 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EMSI % Intertek Testing Services NA, Inc. Mr. Daniel W. Lehtonen 2307 E. Aurora Road Unit B7 Twinsburg, Ohio 44087

Re: K083030

Trade/Device Name: TENS-EMS-14 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ, IPF Dated: January 19, 2009 Received: January 21, 2009

Dear Mr. Lehtonen:

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 - Mr. Daniel W. Lehtonen

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark H. Millers

· 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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EMSI TENS-EMS-14

Section 4: Indications for Use Statement

510(k) Number: To be assigned

TENS-EMS-14 Device Name:

Indications for Use:

TENS- Transcutaneous Nerve Stimulation

• Symptomatic relief of chronic intractable pain .
• Post traumatic and post surgical pain relief

EMS- Electrical Muscle Stimulation

• Relaxation of muscle spasm
• Increasing local blood circulation
• Muscle re-education
• Prevention or retardation of disuse atrophy
• Prevention of venous thrombosis of the calf muscles immediately after surgery

Maintaining or increase range of motion

Prescription Use X	AND/OR	Over-The-Counter Use _
(Part 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)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number_\hspace{1cm}10803030

Page 1 of_

Electrostim Medical Services, Inc.

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).