MEDSTAR 150

K013081 · Mednet Services, Inc. · IPF · Nov 20, 2001 · Physical Medicine

Device Facts

• Record ID: K013081
• Device Name: MEDSTAR 150
• Applicant: Mednet Services, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Interferential Stimulation is used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are: . Symptomatic relief and management of chronic pain and/or . an adjunctive treatment in the management of post surgical and posttraumatic acute pain. When used for neuromuscular stimulation, the standard indications for use are: . 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 rang of motion

Device Story

MEDSTAR 150 is a DC battery-powered muscle stimulator; generates small electrical current pulses. Pulses delivered via lead cables to skin-surface electrodes; current passes through skin to activate underlying nerves and muscle. Used under medical supervision in clinical settings for pain management and neuromuscular stimulation. Healthcare providers apply electrodes and adjust settings to achieve therapeutic goals; output affects muscle activity and nerve signaling to provide symptomatic relief or physical therapy benefits.

Clinical Evidence

Bench testing only. Functional safety testing performed using a signal generator, voltmeter, and resistor to verify impedance and output characteristics.

Technological Characteristics

DC battery-powered electrical stimulator. Delivers pulses via lead cables and skin electrodes. Functional safety verified via signal generator and voltage drop measurements. Class II device.

Indications for Use

Indicated for patients requiring adjunctive therapy for pain relief (chronic, post-surgical, or post-traumatic acute pain) or neuromuscular stimulation (muscle spasm relaxation, prevention of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf stimulation to prevent venous thrombosis, and maintenance/increase of range of motion). Use under medical supervision.

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

• 4000+ Interferential Powered Muscle Stimulator (K950783)

Submission Summary (Full Text)

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#### A. 510(k) Summary

## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | K013081 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | MedNet Services, Inc.<br>2855 Anthony Lane, Suite B-10<br>St. Anthony, MN 55418<br>Phone: [phone]<br>Fax: [phone] |
| CONTACT PERSON: | David L. Mathews |
| TITLE: | President |
| DATE PREPARED: | September 11, 2001 |
| TRADE NAME: | MEDSTAR™ 150 |
| COMMON NAME: | Powered Muscle Stimulator (89IPF) |
| CLASSIFICATION: | 21 CFR 890.5850, Powered Muscle<br>Stimulator Class II |
| PRODUCT CODE: | IPF, LIH |
| PREDICATE DEVICE (S): | 4000+ Interferential Powered Muscle Stimulator,<br>K950783 |

DEVICE DESCRIPTION:
The MEDSTAR 150 is a DC battery powered device that generates small pulses of electrical current. These small pulses of electrical current are delivered through lead cables to electrodes placed on the skin. These electrical pulses pass through the skin and activate underlying nerves and muscle.
INTENDED USE:
Interferential Stimulation is used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:108

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K013081
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- . Symptomatic relief and management of chronic pain and/or
- . an adjunctive treatment in the management of post surgical and posttraumatic acute pain.

When used for neuromuscular stimulation, the standard indications for use are:

- 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 rang of motion

### FUNCTIONAL SAFETY TESTING:

Was performed with a signal generator voltmeter, 20 ohm resistor, and alligator clip wires. The signal generator was set to 1000 Hz and V ¡ was set at approximately 2 volts. The voltage drop across the electrodes (V2) was measured and the impedance of the electrodes calculation is as follows:

Impedance (Z) = V7/V1 x R Where V2 and V; are the voltage meter readings.

Refer to section 6 for further details.

CONCLUSION:

The MEDSTAR 150 is substantially equivalent to 4000+ Interferential Powered Muscle Stimulator in intended use, design and performance.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2001

Mr. David L. Mathews President MedNet Services, Inc. 2855 Anthony Lane, Suite B-10 St. Anthony, Minnesota 55418

Re: K013081

Trade/Device Name: MEDSTAR™ 150 Interferential and Powered Muscle Stimulator Regulation Number: 890.5850 and unclassified Regulation Name: Powered muscle stimulator and Interferential current therapy Regulatory Class: II Product Code: IPF, LIH Dated: September 11, 23001 Received: September 14, 2001

Dear Mr. Mathews:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 20, 1970, in easondance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, diereleve, mains 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 If your device is elassinod (600 as controls. Existing major regulations affecting your device can may oe subject to such additions, 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 I lease of advisou that I Drivisantes over device complies with other requirements of the Act that I DI Has made a cond regulations administered by other Federal agencies. You must or any I odetar states and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Part 607), adoning (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David L. Mathews

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and h your finding of substantial equivalence of your device to a legally premated predicated. " cresults 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 [phone]. 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). regaration childred, which on your responsibilities under the Act may be obtained from the O wision 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 M Mullener

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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NOV 2 0 2001

K013081

# Indications For Use Page

510(k) Number (if known): Not yet assigned.

Device Name: MEDSTAR 150

#### Indications For Use:

The MEDSTAR 150 should only be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:

- symptomatic relief and management of chronic pain and/or .
- an adjunctive treatment in the management of post surgical and posttraumatic acute ● pain.

When used for neuromuscular stimulation, the standard indications for use are:

- 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 rang of motion .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Minh N Mulkerson

510(k) Nu: K013081

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