GS 3000

K102202 · Emsi · IPF · Nov 23, 2010 · Physical Medicine

Device Facts

• Record ID: K102202
• Device Name: GS 3000
• Applicant: Emsi
• Product Code: IPF · Physical Medicine
• Decision Date: Nov 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

As prescribed by a physician for the following: Relaxation of muscle spasm Increasing local blood circulation Maintaining or increasing range of motion Preventing or retarding disuse atrophy Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Device Story

GS 3000 is a single-channel High Voltage Pulsed Galvanic Current (HVPGC) stimulator; delivers electrical stimulation via skin-attached electrodes. Device features twin peak monophasic waveform with 5 usec fixed duration; amplitude adjustable 0-350V; frequency 2-100 cycles per second. Powered by 9V battery. Clinician-prescribed; used for muscle spasm, circulation, range of motion, atrophy, re-education, and post-surgical thrombosis prevention. Output parameters controlled by user to elicit muscle response.

Clinical Evidence

Bench testing only. Device performance verified against IEC 60601-1 (General Safety) and IEC 60601-1-2 (Electromagnetic Compatibility) standards. Testing confirmed safety regarding electrical leakage current, electrode/lead wire integrity, and output power density.

Technological Characteristics

High Voltage Pulsed Galvanic Current (HVPGC) stimulator. Twin peak monophasic waveform; 5 usec fixed pulse duration. Amplitude 0-350V; frequency 2-100 Hz. Single channel; selectable polarity and treatment modes. 9V battery powered. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for patients requiring muscle stimulation for spasm relaxation, blood circulation improvement, range of motion maintenance, disuse atrophy prevention, muscle re-education, and post-surgical venous thrombosis prevention.

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

• Skylark Device Company PGS 123 (K946299)

Submission Summary (Full Text)

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102202 NOV 2 3 2010

## Section 5: 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for the GS 3000 510(k) premarket notification for and in accordance with FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s" June 9, 1999.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the GS 3000 is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.

| Applicant: | EMSI<br>3504 Cragmont Dr. Suite#100<br>Tampa, FL 33619<br>Ph: 813-471-0129<br>Fax: [phone]<br>Registration Number: 3003573572 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Cherita James<br>M Squared Associates, Inc<br>901 King Street, Suite 200<br>Alexandria, VA 22314<br>Phone: [phone] Ext. 257<br>Facsimile: 703-562-9797 |
| Date of submission: | August 3, 2010 |
| Proprietary Name: | GS 3000 |
| Common Name: | Powered Muscle Stimulator |
| Classification Status: | 21 CFR 890.5850 |
| Product Code: | IPF |
| Panel: | Physical Medicine |
| Predicate Device: | Skylark Device Company PGS 123 K946299 |

Device Description: . The GS 3000 is a High Voltage Pulsed Galvanic Current (HVPGC) Stimulator which delivers stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The device has a twin peak monophasic waveform with a

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5 usec fixed duration. The current Amplitude is adjustable from 0-350 Volts (0~190V Max @ 500ohm resistance), with an adjustable pulse frequency range from 2-100 cycles per second.

The GS 3000 is a single channel device, with the option to set the active electrodes (treatment electrode) to either positive or negative polarity in relation to the dispersive electrode (closes patient circuit) and alternating or synchronous treatment mode selection. The device is powered by a 9 volt battery.

Intended Use: As prescribed by a physician for the following:

Relaxation of muscle spasm

Increasing local blood circulation

Maintaining or increasing range of motion

Preventing or retarding disuse atrophy

Muscle re-education

Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Discussion of performance testing: Testing performed in accordance with the accepted FDA requirements of IEC 60601-1, found the GS 3000 met all applicable requirements. Based on the output measurements, calculations, and safety testing/inspection conducted; the GS 3000 is safe with respect to electrical leakage current, electrode and lead wire safety, as well as output current and power density. Testing performed in accordance with the accepted FDA requirements of IEC 60601-1-2, Medical Electrical Equipment, Part 1: General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility- Requirements and Test, found the GS 3000 met all applicable requirements.

## Technological Characteristics and Substantial Equivalence

Output specifications, device design, and waveforms demonstrated the GS 3000 to be substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Electrostim Medical Services, Inc. % M Squared Associates, Inc. Ms. Cherita James 901 King Street, Suite 200 Alexandria, Virginia 22314

Re: K102202

Trade Name: GS 3000 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: October 27, 2010 Received: October 28, 2010

NOV 2 3 2010

Dear Ms. James:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Cherita James

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Mark A. Millkenna

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4: Indications for Use Statement

| 510(k) Number: | To be assigned |
|----------------------|--------------------------------------------------------------------------------------|
| Device Name: | GS 3000 |
| Indications for Use: | Relaxation of muscle spasm |
| | Increasing local blood circulation |
| | Maintaining or increasing range of motion |
| | Preventing or retarding disuse atrophy |
| | Muscle re-education |
| | Immediate post-surgical stimulation of calf muscles to prevent<br>venous thrombosis. |

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

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Division of Surgh
and Restorative Devices

510(k) Number J

1. 1. 1. 1. 1. 1. 1.