ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607

K033544 · Everyway Medical Instruments Co.,Ltd · IPF · Dec 10, 2003 · Physical Medicine

Device Facts

• Record ID: K033544
• Device Name: ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
• Applicant: Everyway Medical Instruments Co.,Ltd
• Product Code: IPF · Physical Medicine
• Decision Date: Dec 10, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electrical Muscle Stimulator Series (Model Numbers N605, N607) 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

Electrical Muscle Stimulator (Models N605, N607) is an analog, electrically powered device; delivers electrical currents through skin-contacting electrodes to induce muscle contraction. Used for therapeutic purposes including spasm relaxation, circulation improvement, and atrophy prevention. Operated by adjusting physical buttons to control output amplitude, pulse width, pulse rate, and ramp time. Device serves as an analog version of the previously marketed digital EV-807 stimulator. Healthcare providers or patients use the device to manage muscle-related conditions; output directly affects muscle activity to achieve clinical goals.

Clinical Evidence

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

Technological Characteristics

Analog powered muscle stimulator; delivers electrical current via electrodes. Features adjustable output amplitude, pulse width, pulse rate, and ramp time. Class II device (21 CFR 890.5850).

Indications for Use

Indicated for patients requiring muscle contraction for 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

• Digital EMS, model EV-807 (K020750)

Submission Summary (Full Text)

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K033544

DEC 1 0 2003

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

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)

(886) 2 2662 0038 3-Phone:

(886) 2 2664 5566 4-Fax:

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

6-Date summary prepared: November 3rd, 2003

7 - Official Correspondent: Mansour Consulting LLC

8- Address: 1308 Momingside Park Dr. Alpharetta, GA 30022 USA

9- Phone: [phone]

10- Fax: [phone]

11- Contact Person: Jay Mansour, President

12-Device Trade or Proprietary Name: Electrical Muscle 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 include technical specifications (Output amplitude, range of pulse width, pulse rate, ramp time), buttons to adjust parameters and shape unit. Basically the change is from digital version to analogue version of EMS. The specifications of units are modified according to the requirements of customers while are still very similar to the predicated unit.

The intended use of the modified devices is the same as for the predicate device. In addition, the scientific technology, manufacturing methods, and 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)

Electrical Muscle Stimulator Series (Model Numbers N605, N607) 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 ー
- Preventing or retarding disuse atrophy -

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### 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)

#### 14-Summary comparing technological characteristics with predicate device:

Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SUBSTANTIALLY EQUIVALENT to the predicate device. Refer to the explanations/details within the main submission.

| FDA file reference number | 510k # K020750 |
|-----------------------------------------------------|-------------------|
| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Not Applicable |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Not Applicable |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and<br>other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| Thermal safety | Identical |
| Radiation safety | Not Applicable |

Refer to the submission for more details.

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DEC 1 0 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: K033544

Trade/Devicc Name: Electrical Muscle Stimulator, Models N605 and N607 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: November 3, 2003 Received: November 10, 2003

Dear Mr. Mansour:

We have reviewed your Scction 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. 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 vours.

Mark McMullan

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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### Indications for Use

510(k) Number (if known): K C 335544

Device Name: ELECTRICAL MUSCLE STIMULATIR - HODELS N603KN607

Indications For Use:

ELECTRICAL MUSCLE STIMULATOR SERIES 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 ARGA.

IN PORTICULAR, THIS DEVICE IS INDICATED FOR USE for 2

- RELAXING MUSCLE SPASHS
- INCREASING LOCAL BLOGO CIRCULATIon
- INCESSION BEST SURGICAL STIMULATION of CALF MUSELES TO PECIENT THROMBOSIS
- MUSCLE RE-EDUCATION
- MAINTAINING OR INCREASING RANGE of MOTIO
- PREVENTING OR RETARDING DISUSE

Over-The-Counter Use AND/OR Prescription 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)

Mark N. Millican

Cock Restorative carological Devices

(k) Number K033544

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