NEUROTECH MEDISTIM PLUS, TYPE 291

K014019 · Bio-Medical Research, Ltd. · IPF · Jul 11, 2002 · Physical Medicine

Device Facts

• Record ID: K014019
• Device Name: NEUROTECH MEDISTIM PLUS, TYPE 291
• Applicant: Bio-Medical Research, Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Jul 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MediStim PLUS is intended for use with a wide range of patients, some of who may have limited dexterity. It is intended to use the principles of neuromuscular electrical nerve stimulation through skin contact surface electrodes for the purpose of activation of weak and atrophied muscles or the inhibition of overactive muscle.

Device Story

Portable, two-channel, battery-operated neuromuscular electrical stimulator; delivers electrical stimulation via skin surface electrodes. Used for muscle activation or inhibition. Operated by patient or clinician in clinical or home settings. Device includes LCD screen for user compliance monitoring. Healthcare provider uses device to manage muscle atrophy, spasms, or post-surgical recovery. Benefits include improved muscle function, circulation, and range of motion.

Clinical Evidence

Bench testing only. Device tested for compliance with IEC 601-1 (1998, 1991, 1995), IEC 601-2-10 (1987), and IEC 601-1-2 (1993). Hazard, risk, and failure mode effects analysis performed.

Technological Characteristics

Portable, two-channel, 9V battery-powered neuromuscular stimulator. Includes LCD screen, lead wires, and adhesive skin surface electrodes. Adheres to IEC 601-1, IEC 601-2-10, and IEC 601-1-2 standards.

Indications for Use

Indicated for relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, and maintaining or increasing range of motion.

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

• Staodyn EMS +2

Submission Summary (Full Text)

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JUL 11 2002

# 510(k) Summary of safety and effectiveness.

# This summary is submitted in accordance with 21 CFR 807.92

| a) Submitted by | Bio-Medical Research Ltd<br>BMR House<br>Parkmore Business Park, West<br>Galway<br>Republic of Ireland. |
|----------------------------------------|---------------------------------------------------------------------------------------------------------|
| Contact person | Michelle Sawyer |
| Phone | [phone] |
| Fax | [phone] |
| e-mail | [e-mail] |
| Title | Regulatory Affairs Specialist |
| Date of preparation | 04 December 2001. |
| Trade name of Device | NT MediStim PLUS |
| Common name | Powered muscle stimulator |
| Classification name | External functional neuromuscular<br>stimulator |
| Identification of predicate<br>Device. | Staodyn EMS +2 |

## Description of the device.

The MediStim PLUS is a portable two-channel battery operated neuromuscular electrical stimulator. The device is intended for prescriptive use per 21 CFR 801,109. It comprises of the device and two colour differentiated lead wires. which connect to four skin surface electrodes.

The device is powered by a 9-volt (type 6/22) battery located in a compartment to the rear of the device with a detachable batterv cover.

The device is supplied with a set of adhesive electrodes, a carrying case, the user instruction manual and a battery.

Built in safety features are clearly outlined in this submission, which greatly reduce the possibility of mis-use.

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SKI

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## Intended use.

The MediStim PLUS is intended for use with a wide range of patients, some of who may have limited dexterity. It is intended to use the principles of neuromuscular electrical nerve stimulation through skin contact surface electrodes for the purpose of activation of weak and atrophied muscles or the inhibition of overactive muscle.

「echnological comparison.

The MediStim PLUS is similar to the EMS+2 in that it delivers a stimulation signal. which is almost identical with similar parameter settings. The MediStim PLUS has an LCD screen with user compliance monitoring, where as the EMS+2 does not have this feature.

Non-clinical tests.

The MediStim PLUS was designed to. and has been independently tested to IEC 601-1: 1998 +A1: 1991+ A2: 1995, IEC 601-2-10:1987. IEC 601-1-2:1993.

Bio-Medical Research LTD adheres to recognised and established industry practices and all devices are subject to final performance testing.

A Hazard analysis, risk analysis and failure mode effects analysis have been carried out for the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 11 2002

Mrs. Michelle Sawyer Bio-Medical Research Ltd. BMR House Parkmore Business Park West Galway, Ireland

Re: K014019

Trade/Device Name: Neurotech Medstim PLUS, Type 291 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: April 10, 2002 Received: April 15, 2002

## Dear Mrs. Sawyer:

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 (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. This letter will allow you to begin marketing your device as described in your Section 510(k)

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### Page 2 - Mrs. Sawyer

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 (301) 594-. 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,

Styph Rhodes

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 statement

510(k) number (if known):

Not available

014019

Device Name:

NeuroTech MediStim PLUS, Type 291.

Sponsor Name:

Bio-Medical Research Ltd. (NeuroTech is a division of Bio-Medical Research Ltd.)

Indications for use.

The MediStim PLUS is indicated for:

- Relaxation of muscle spasms .
- Prevention or retardation of disuse atrophy �
- Increasing local blood circulation �
- Muscle re-education .
- Immediate post-surgical stimulation of calf muscles to prevent . venous thrombosis
- Maintaining or increasing range of motion.

Do Not Write Below This Line -Continue on Another Page if Needed,

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use

Over -The -Counter- Use

Styph Clurle

Division of General, Restorative and Neurological Devices

510(k) Number_ 5014019