STIM-8

K955736 · Bmr , Ltd. · IPF · May 22, 1996 · Physical Medicine

Device Facts

• Record ID: K955736
• Device Name: STIM-8
• Applicant: Bmr , Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: May 22, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stim-8 is used for stimulation of muscles for the purposes of 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.

Device Story

Stim-8 is a compact, battery-powered muscle stimulator; delivers transcutaneous electrical pulses to skeletal muscles via skin surface electrodes. Four independent channels; user controls limited to amplitude intensity; all other stimulation parameters fixed. Used in clinical or home settings for muscle therapy. Device utilizes microprocessor-controlled stimulation; output transformer impedance ensures near net zero charge delivery to skin. Healthcare providers or patients use device to facilitate muscle contraction; benefits include spasm reduction, atrophy prevention, improved circulation, and post-surgical thrombosis prophylaxis.

Clinical Evidence

No clinical testing was performed. Safety and effectiveness supported by bench testing of stimulation output parameters and adherence to EN 60601-1-2 (IEC 601-1-2) standards.

Technological Characteristics

Battery-powered, portable muscle stimulator. Microprocessor-controlled stimulation parameters. Four independent channels. Output transformer impedance design for near net zero charge delivery. Standard skin surface electrodes. Tested to EN 60601-1-2 (IEC 601-1-2).

Indications for Use

Indicated for patients requiring muscle stimulation for relaxation of muscle spasms, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf muscle stimulation to prevent venous thrombosis, and maintenance/increase of 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

• NeuroTech-16 Program System Controller Model 280 (K860315)

Submission Summary (Full Text)

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K955736

# 510(k) Notification for Stim-8: Appendix IX

## 510(k) Summary of Safety and Effectiveness

This summary is submitted in compliance with the FDA interim rule 21 CFR 807.92.

(a) (1) Submitted by:
BMR Ltd.,
Research & Development,
1622 Merchants Road,
Galway.
Republic of Ireland

Telephone: [phone]
Fax:: [phone]

Contact Person: Isaac Finnegan
Position/ Title: Design Engineer - Regulatory Affairs
Date of preparation: 12 December, 1995

(2) Trade name of device: Stim-8
Common name: Muscle Stimulator
Classification name: Powered muscle stimulator; §890.5850

(3) Identification of predicate or legally marketed device: NeuroTech-16 Program System Controller Model 280 (NeuroTech Inc., 510(k) # K860315)

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# 510(k) Notification for Stim-8: Appendix IX

## (4) Description of device:

The Stim-8 is a compact, battery powered muscle stimulator. It is used to repetitively contract skeletal muscles by providing transcutaneous electrical pulses to areas of the body that require therapy for the indicated medical conditions. The parameters of the Stim-8 cannot be set by the user. Four channels are available on the Stim-8. Each channel operates independently and if desired one, two, three or four channels may be used simultaneously. The only controllable parameters are the amplitude intensity controls of the stimulation.

## (5) Intended uses:

The Stim-8 is used for stimulation of muscles for the purposes of 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.

These uses are similar to the predicate marketed device identified in section (3) of this summary.

## (6) Technological comparison

The Stim-8 is similar the NeuroTech-16 Program System Controller in that both utilize microprocessor controlled stimulation parameters. Output for either device is suitable for muscle stimulation using standard skin surface electrodes. Both devices are similar in basic operational design and use the impedance of the output transformer to achieve a near net zero charge into the skin. The Stim-8 is effectively a more limited, portable version of the NeuroTech-16 Program System Controller with a replaceable battery.

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# 510(k) Notification for Stim-8: Appendix IX

(b) (1) Non-clinical tests:

Comparisons of stimulation outputs for the Stim-8 and the predicate NeuroTech-16 Program System Controller show similar results that are suitable for muscle stimulation. To minimize potential electrical and mechanical hazards, BMR adheres to recognised and established industry practice and all devices are subject to final performance testing. The Stim-8 is designed and tested to EN 60601-1-2 (IEC 601-1-2).

(2) Clinical tests:

No clinical testing was performed.

(3) Test conclusions:

Testing of the stimulation output parameters of the Stim-8 indicate that the device is safe, that it provides appropriate stimulation output for effective muscle stimulation and that it performs as well as or better than the legally marketed predicate device identified in section (3) of this Summary.

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