NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P

K033140 · Everyway Medical Instruments Co.,Ltd · IPF · Oct 29, 2003 · Physical Medicine

Device Facts

• Record ID: K033140
• Device Name: NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
• Applicant: Everyway Medical Instruments Co.,Ltd
• Product Code: IPF · Physical Medicine
• Decision Date: Oct 29, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EV-807P Electrical Muscle Stimulator 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 - - 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-807P is an electrically powered muscle stimulator; delivers electrical currents through skin-contacting electrodes to induce muscle contraction. Modification of predicate EV-807; features include linear increase of output current, expanded parameter programming options for physical therapists, and dual-channel output configurations. Used in clinical settings by physical therapists or clinicians to treat muscle spasms, improve circulation, prevent venous thrombosis, re-educate muscles, maintain range of motion, and retard disuse atrophy. Device output is controlled by the clinician to tailor stimulation parameters to patient needs, facilitating therapeutic muscle contraction.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance comparisons to the predicate device.

Technological Characteristics

Powered muscle stimulator (21 CFR 890.5850); dual-channel output; electrical stimulation via surface electrodes. Modifications include linear output current control and expanded parameter programming. Electrical and thermal safety characteristics are identical to the predicate.

Indications for Use

Indicated for patients requiring muscle stimulation for relaxation of muscle spasms, increased local blood circulation, prevention of venous thrombosis via post-surgical calf muscle stimulation, muscle re-education, maintenance or increase of range of motion, and prevention or 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

• Digital EMS, model EV-807 (K020750)

Submission Summary (Full Text)

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K033140

OCT 2 9 2003

As Required by 21 section 807.92 ( c )

510(k) Summarv

Everyway Medical Instruments Co., Ltd 1-Submitter Name:

- 3FL. No.5. LANE 155. Sec. 3. Peishen Rd 2-Address:
- Shen Keng Hsiang. Taipei Hsien. Taiwan (ROC)
- (770) 777- 4146 3-Phone:

(678) 623- 3765 4-Fax:

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

- 6-Date summary prepared: September 25th, 2003
- 7 Official Correspondent: Mansour Consulting LLC
- 8- Address: 1308 Morningside Park Dr. Alpharetta, GA 30022 USA
- 9- Phone: [phone]

10- Fax: [phone]

- 11- Contact Person: Jay Mansour, President
- 12-Device Trade or Proprietary Name: Neuromuscular Electrical Stimulator

13-Device Common or usual name: EMS

- 14-Device Classification Name: Stimulator, muscle, powered
- 15-Substantial Equivalency is claimed against the following device:
- Digital EMS, model EV-807 from Everyway Medical Instruments Co., Ltd. . 510k# K020750

## 16-Description of the Device:

The Special 510(k) premarket notification describes a modification to Everyway's currently legally marketed EV-807 Digital Electrical Stimulator. The proposed modifications including linearly increase of output current, more programs for the physical therapist to create different parameters, more options of output type between 2 channels and device case. The modifications of the predicate device make the stimulation even more comfortable and effective.

The intended use of the modified devices is the same as for the predicate device. In addition, the scientific technology, manufacturing methods, operating principles for the changed devices are equivalent to those of the predicate device.

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

EV-807P Electrical Muscle Stimulator 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 -
- Increasing local blood circulation. ﻤ
- 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 -

## 18-Safety and Effectiveness of the device:

This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

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

Please find below a tabulated comparison supporting that EV-807P is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency detailed chart path is attached.

| FDA file reference number | 510k # of predicate : K020750 |
|-------------------------------------------------|-------------------------------|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Nor Applicable |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Not Applicable |
| Anatomical sites | Not Applicable |
| Human factors | Not Applicable |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other | Identical |
| devices | |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| Thermal safety | Identical. |
| Radiation safety | Not Applicable. |

Detailed technical comparison is included within main submission

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines beneath them.

Public Health Service

OCT 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Everyway Medical Instruments Co., Ltd. C/o Mr. Jay Mansour, MSQA, BE, LA, RAC President Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, Georgia 30022

Re: K033140

Trade/Device Name: Neuromuscular Electrical Stimulator, EV-807P (Electrical Muscle Stimulator) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: September 25, 2003 Received: September 30, 2003

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 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.

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### Page 2 - Mr. Jay Mansour, MSQA, BE, LA, RAC

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

sincerely yours,

Mark N Millman

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 1 of

#### 510(k) Number (if known): 1633191

Device Name: Neuromuscular Electrical Stimulator, EV-807P (Electrical Muscle Stimulator)

Indications for Use:

EV-807P Electrical Muscle Stimulator 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 -
- 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 -

Marti A. Milkman

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

(033140 510(k) Number -

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

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