DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS

K020750 · Everyway Medical Instruments Co.,Ltd · IPF · Oct 31, 2002 · Physical Medicine

Device Facts

• Record ID: K020750
• Device Name: DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS
• Applicant: Everyway Medical Instruments Co.,Ltd
• Product Code: IPF · Physical Medicine
• Decision Date: Oct 31, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EV-807 Digital EMS 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: - Relaxing muscle spasms. - Increasing local blood circulation. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - Muscle re-education. - Maintaining or increasing range of motion. - Preventing or retarding disuse atrophy

Device Story

EV-807 Digital EMS is a battery-operated pulse generator; delivers electrical impulses via electrodes to underlying muscle groups. Device features two independent output channels; user-adjustable intensity, pulse width, pulse rate, contraction, relaxation, and ramp settings via push buttons. Slide cover prevents accidental setting changes. Used in clinical or home settings under physician direction. Output provides therapeutic muscle contraction to address spasms, circulation, atrophy, and range of motion. Benefits include non-invasive muscle stimulation and post-surgical venous thrombosis prophylaxis.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical technological characteristics and design to the predicate device.

Technological Characteristics

Battery-operated pulse generator; two independent output channels. Complies with EN 60601-1 and EN 60601-1-2. Manufacturing conforms to ISO 9002, EN 46002, and ISO 13488. Device utilizes electrical stimulation for muscle contraction.

Indications for Use

Indicated for patients requiring muscle contraction for medical purposes, including relaxation of muscle spasms, increased local blood circulation, prevention of venous thrombosis via post-surgical calf muscle stimulation, muscle re-education, maintenance/increase of range of motion, and prevention/retardation of disuse atrophy.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• TransAmerica Medical Systems (K010665)

Submission Summary (Full Text)

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# 510(k) Summary

| As Required by 21 section 807.92 ( c ) | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------|
| 1-Submitter Name: Everyway Medical Instruments Co., Ltd | | |
| 2-Address: | 3FL., No. 5, Lane 155, Sec. 3, PeiShen Rd., Shen Ken<br>Hsiang<br>Taipei Hsien<br>Taiwan, R.O.C. | |
| 3-Phone: | 886-2-2662-0038 | OCT 31 2002 |
| 4-Fax: | 886-2664-5566 | |
| 5-Contact Person: Mr Robert Tu (General Manager) | | |
| 6-Date summary prepared: February 27th, 2002 | | |
| 7- Official Correspondent: Mansour Consulting | | |
| 8- Address: | 1308 Morningside Park Dr<br>Alpharetta, GA 30022 USA | |
| 9- Phone: | [phone] | |
| 10- Fax: | [phone] | |
| 11- Contact person: Jay Mansour, president | | |
| 12-Device Trade or Proprietary Name: EV-807 Digital EMS | | |
| 13-Device Common or usual name: Powered Muscle Stimulator | | |
| 14-Device Classification Name: Stimulator, Muscle, Powered | | |
| 15-Substantial Equivalency is claimed against the following device:<br>TransAmerica Medical Systems, 510k #k010665 (refer to Appendix<br>for FDA website printout) | | |

This notification for EV-807 is of the ABBREVIATED type as per the declaration of conformity included in this summary

16-Description of the Device: EV-807 Digital EMS is a battery operated pulse generator that sends electrical impulses through electrodes to the body and reaches the underlying or muscle group. The device is provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel.

The electronics of the EVERYWAY EV-807 DIGITAL EMS create electrical impulses whose intensity, pulse width, pulse rate, contraction, relaxation and ramp may be altered with the switches. Press buttons are very easy to use and the slide cover prevents accidental changes in the setting.

17-Intended use of the device: (Indications for use typed on a separate FDA form) EV-807 Digital EMS 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:

- Relaxing muscle spasms. -
- Increasing local blood circulation. -
- Immediate post-surgical stimulation of calf muscles to prevent venous ﮯ thrombosis.
- -Muscle re-education.
- Maintaining or increasing range of motion. a
- Preventing or retarding disuse atrophy

### 18-Safety and effectiveness of the device:

This device is safe and effective as the predicate device Transamerica Digital EMS. Indeed, it is identical. The same device which was cleared by 510k #k010665 for the distributor TransAmerica Medical Systems is submitted here

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### for the original manufacturer in Taiwan EVERYWAY MEDICAL INSTRUMENTS CO., LTD. Refer to the tabulated comparison (Paragraph 19 below)

## 19-Summary comparing technological characteristics with other predicate device:

| FDA file reference number | 510k #k010665 |
|--------------------------------------------------|------------------------|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Identical |
| Materials | Identical |
| Performance | Identical |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| Thermal safety | Identical |
| Radiation safety | Identical |

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This is to declare and confirm that Everyway Medical Instruments Co., Ltd. conforms in its manufacturing of Electrical Muscle Stimulator EV-807 Digital EMS to the following recognized standards: Standards met and standards tested against

| Inapplicable requirements or deviations | N/A. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of any way(s) in which the standard was adapted for the application of the device, i.e., identification of an alternative series of tests that were performed | |
| Specification of any deviations from each applicable standard | |
| Specification of the differences that may exist between the tested device and the device to be marketed and justification of the test results | |
| Name and address of any test laboratory or certification body involved in determining the conformance of the device with the standard and reference to any accreditations of those organizations | For QSR: Not applicable<br>For ISO 9002: 1994, EN 46002, ISO 13488 and CE Mark:<br>TUV Rheinland Product Safety GmbH-<br>Am Grauen Stein -D-51105 Koln.<br>TUV Rheinland Product Safety GmbH-<br>Am Grauen Stein -D-51105 Koln. |
| Supervision of product and design: QSR (FDA's Quality System Requirements) DIN EN ISO 9002/08.1994 DIN EN 46002/09.1996 EE Directive 93/42 (CE Mark) ISO 13488/12.1996 | |
| Technical standards: EN 60601-1:1990+A1:1993+A2:1995 EN60601-1-2:1993 | |
| Name, Signature and position | Robert Tu/ General Manager |
| Date | 02/27/2002 |

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דער

QTJ, OO STUBMUATSHI JASIDEM YAWYAAVA

# THE ARRENCE OF CORRESSIONAL

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### DEFARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned above the text "DEPARTMENT OF HEALTH" which is part of a circular border around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 31 2002

• Mr. Jay Mansour Representing Everyway Medical Instruments Co., Ltd. Mansour Consulting, L.L.C. 1308 Morningside Park Drive Alpharetta, Georgia 30022

Re: K020750

Trade/Device Name: EV-807 Digital Electrical Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: July 26, 2002 Received: August 1, 2002

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 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

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Page 2 - Mr. Jay Mansour

requirements as set forth in the quality systems (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark N Millican

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

NUMBER 510 (k) KNOWN) ( IC

DEVICE NAME: Digital Electrical Muscle Stimulator (EV-807 Digital EMS)

INDICATIONS FOR USE:

EV-807 Digital EMS 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 indicated for use for:

- Relaxing muscle spasms. a
- Increasing local blood circulation. -
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- Muscle re-education. ।
- Maintaining or increasing range of motion. -
- Preventing or retarding disuse atrophy

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

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Prescription Use (Per 21 CFR 801.109)

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Di icin 7 astorative , and Neurological Devices

510(k) Number K020736

Over-The-Counter-Use (Optional Format 1-2-90