This device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems

APPLICABLE FOR EV-805 (EMS) AND EV-806 (TENS/EMS COMBINATION UNIT):

This device is an electrically powered muscle stimulator indicated for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy

Device Description

The Comfy Series, which includes models EV-804, EV-805, EV-806, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.

The three models have the same housing. The process to set the parameter and attach lead wires to the unit are also the same. Yet, they have different liguid crystal display and parameters for patients to create their own settings.

The EV-804 is a TENS device with 5 modes and adjustable pulse rate, pulse width and timer. The EV-805 is an EMS device with 3 modes and adjustable pulse rate, pulse width, contraction time, relaxation time, ramp time and timer. The EV-806 is a combination unit with both TENS and EMS functions. The function can be selected by press buttons. The range of settings are identical to those of EV-804 and EV-805. The difference on the three units can be identified by the liquid crystal display.

AI/ML Overview

The provided text is a 510(k) summary for the Comfy series of TENS/EMS devices (Models EV-804, EV-805, EV-806). This type of submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than conducting new clinical studies with defined acceptance criteria for device performance.

Therefore, the document does not contain the kind of information requested in the prompt, such as specific acceptance criteria, a study proving device performance against those criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Instead, the submission relies entirely on the premise that the new devices are safe and effective because they are substantially equivalent to previously cleared devices (Everyway Medical Instruments Co., Ltd.'s Digital TENS model EV-803, 510k# K020749, and Digital EMS model EV-807, 510k# K020750).

Here's a breakdown of why the requested information is absent:

Acceptance Criteria and Reported Performance: The document states, "This series is safe and effective as the predicate devices cited above. The design modifications that EV-803 and EV-807 underwent did not affect safety and effectiveness of the new series EV-804, EV-805 and EV-806 as detailed within this submission." There are no new performance metrics or acceptance criteria presented because the claim is an equivalence to existing, already-cleared devices.
Study Design/Sample Sizes/Data Provenance/Ground Truth/Adjudication/MRMC/Standalone Performance: These elements are typical of de novo clinical studies demonstrating the safety and effectiveness of a novel device. For a 510(k) based on substantial equivalence, especially for a device like a TENS/EMS unit with well-established technology, such studies are generally not required if the new device can be shown to have the same intended use, technological characteristics, and performance characteristics as a predicate device, or if any differences do not raise new questions of safety and effectiveness.

In summary, the provided text does not describe a study to prove the device meets acceptance criteria in the way a novel device might. It describes a submission to the FDA based on substantial equivalence.

Summary

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K07/951/

SEP - 5 2007

510(k) Summary As Required by 21 section 807.92 ( c )

Everyway Medical Instruments Co., Ltd 1-Submitter Name: 3 FL., No.5, LANE 155, Sec. 3, Peishen Rd 2-Address: Shen Keng Hsiang. 222 Taipei Hsien. Taiwan (ROC) (886) 2 2662 0038
3-Phone: (886) 2 2664 5566
4-Fax:

Mr Robert Tu (General Manager) 5-Contact Person:

6-Date summary prepared: July 10th, 2007
7 Official Correspondent: Mansour Consulting LLC
8- Address: 845 Aronson Lake Court. Roswell, GA 30075 USA
9- Phone: 678-908-8180
10- Fax: 678-623-3765
11- Contact Person: Jay Mansour, President

12-Device Trade or Proprietary Name:

(a) Comfy TENS (Model EV-804)
(b) Comfy EMS (Model EV-805)
(c) Comfy STIM (Model EV-806)

13-Device Common or usual name:

(a) TENS UNIT
(b) EMS UNIT
(c) TENS/EMS COMBINATION UNIT

14-Device Classification Name:

(a) Stimulator, nerve, transcutaneous, for pain relief
(b) Stimulator, muscle, powered
(c) Combination of (i) Stimulator, nerve, transcutaneous, for pain relief AND (ii) Stimulator, muscle, powered
15-Substantial Equivalency is claimed against the following device:
- · Digital TENS, model EV-803 from Everyway Medical Instruments Co., Ltd. 510k# K020749
- · Digital EMS, model EV-807 from Everyway Medical Instruments Co., Ltd. 510k# K020750

16-Description of the Device:

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a combination unit with both TENS and EMS functions. The function can be selected by press buttons. The range of settings are identical to those of EV-804 and EV-805. The difference on the three units can be identified by the liquid crystal display.

17-Intended use of the device: (refer to FDA form attached)

The intended Use of Comfy TENS, Model EV-804 TENS is as follows:

This device is an electrical nerve stimulator intended for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is intended for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems

The Intended Use of Comfy EMS, Model EV-805 EMS is as follows:

This device is an electrically powered muscle stimulator intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is intended for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation. (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy

The Intended Use of Comfy Stim, Model EV-806 TENS/EMS Combination Unit are as follows:

This combination device is intended for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is intended for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems

It is also intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is intended for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy

18-Safety and Effectiveness of the device:

This series is safe and effective as the predicate devices cited above. The design modifications that EV-803 and EV-807 underwent did not affect safety and effectiveness of the new series EV-804, EV-805 and EV-806 as detailed within this submission.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Everyway Medical Instruments Co., Ltd. C/O Jay Mansour President Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075

SEP - 5 2007

Re: K071951

Trade Name: Comfy Series, Models EV-804, EV-805, and EV-806 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF and GZJ Dated: August 10, 2007 Received: August 15, 2007

Dear Mr. Mansour:

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

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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Page 2 -- Mr. Jay Mansour

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. 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Neil R. Oyler

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

Enclosure

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Indications for Use

510(k) Number (if known): K071951

Device Name: COMFY SERIES EV-804, EV-805 & EV-806

Indications For Use:

APPLICABLE FOR EV-804 (TENS) AND EV-806 (TENS/EMS COMBINATION UNIT):

APPLICABLE FOR EV-805 (EMS) AND EV-806 (TENS/EMS COMBINATION UNIT):

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

Over-The-Counter Use (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)

Neil RP Ogden for mxm

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

Page 1 of 1

510(k) Number

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).