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

Device Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the Everyway Medical Instruments Co., Ltd Electrical Muscle Stimulator (Models N605 and N607). It describes the device, its intended use, and claims substantial equivalence to a predicate device (Digital EMS, model EV-807 from Everyway Medical Instruments Co., Ltd., 510k# K020750).

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific quantitative acceptance criteria or results from a performance study demonstrating that the device meets those criteria. Instead, it relies on a comparison table to the predicate device to claim substantial equivalence.

Acceptance Criteria Category	Predicate Device Performance / Claim	New Device Performance / Claim
Indications for Use	Identical	Identical
Target Population	Identical	Identical
Design	Similar (Digital to Analog)	Similar
Materials	Similar	Similar
Performance	Similar	Similar
Sterility	Not Applicable	Not Applicable
Biocompatibility	Identical	Identical
Mechanical Safety	Identical	Identical
Chemical Safety	Not Applicable	Not Applicable
Anatomical Sites	Identical	Identical
Human Factors	Similar	Similar
Energy Used/Delivered	Similar	Similar
Compatibility with Environment and Other Devices	Identical	Identical
Where Used	Identical	Identical
Standards Met	Identical	Identical
Electrical Safety	Identical	Identical
Thermal Safety	Identical	Identical
Radiation Safety	Not Applicable	Not Applicable

2. Sample Size for the Test Set and Data Provenance

The document does not mention a specific test set, sample size, or any data provenance (country of origin, retrospective/prospective) for a performance study. The submission primarily relies on a comparative analysis to a predicate device rather than independent testing for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the submission does not describe a performance study with a test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the submission does not describe a performance study with a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or reported in this submission. The effectiveness is claimed through substantial equivalence to a predicate device. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This is not applicable. The device is an Electrical Muscle Stimulator, not an AI algorithm. Performance is claimed through substantial equivalence to a predicate device, which is also an Electrical Muscle Stimulator.

7. Type of Ground Truth Used

This is not applicable in the context of a diagnostic test or AI algorithm. The "ground truth" in this submission is the established safety and effectiveness of the predicate device, which the new device claims to be substantially equivalent to.

8. Sample Size for the Training Set

This is not applicable. The device is a medical instrument (Electrical Muscle Stimulator), not an AI system that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for an Electrical Muscle Stimulator.

Summary of Device Acceptance:

The acceptance of the Electrical Muscle Stimulator (Models N605 and N607) by the FDA was based on substantial equivalence to a legally marketed predicate device (Digital EMS, model EV-807, K020750) rather than a new clinical study with specific acceptance criteria and performance data. The manufacturer demonstrated that the modified device, despite changes from digital to analog and adjustments in technical specifications (output amplitude, pulse width, pulse rate, ramp time), buttons, and unit shape, had identical or similar characteristics to the predicate device across various aspects including indications for use, target population, design, materials, performance, safety, and standards met. The FDA's decision letter confirms that the device was found substantially equivalent to predicate devices, thus permitting it to enter the market subject to general controls. No new clinical trials or performance studies with specific acceptance criteria were needed for this 510(k) submission.

Summary

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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: 770-777-4146

10- Fax: 678-623-3765

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 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
TECHNOLOGICALCHARACTERISTICS	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 andother 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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Image /page/2/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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:

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

Page 1 of

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
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.(b)
Classification. Class II (performance standards).