SYS*STIM 208 AND 208A

K031017 · Mettler Electronics Corp. · IPF · May 30, 2003 · Physical Medicine

Device Facts

• Record ID: K031017
• Device Name: SYS*STIM 208 AND 208A
• Applicant: Mettler Electronics Corp.
• Product Code: IPF · Physical Medicine
• Decision Date: May 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain. 2. Temporary relaxation of muscle spasm. 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles. 4. Increase of blood flow in the treatment area. 5. Prevention or retardation of disuse atrophy in post-injury type conditions. 6. Muscle re-education. 7. Maintaining or increasing range of motion.

Device Story

The Sys*Stim 208/208A is a microprocessor-controlled, portable electrical muscle stimulator. The device delivers low-volt, asymmetrical, electrically balanced biphasic waveforms to the patient via one (Model 208) or two (Model 208A) channels. The clinician selects treatment parameters—including pulse frequency (1-80 Hz), tetanize, and surge modes—using manual knobs and buttons. The device features an optional patient-operated termination switch for safety. The output is used to stimulate muscles for therapeutic purposes, such as re-education, spasm relaxation, or circulation improvement. The device is intended for professional clinical use. It operates on AC power and includes an automatic shut-off timer. The healthcare provider monitors the patient's response to the stimulation to adjust intensity and treatment duration, aiming to achieve the specified therapeutic outcomes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics, including waveform analysis, electrical output specifications, and safety compliance.

Technological Characteristics

Powered muscle stimulator; 110V AC power source; ABS plastic housing; microprocessor-controlled; asymmetrical biphasic rectangular waveform; 1-80 Hz frequency range; 1 or 2 channels; constant voltage output; manual intensity/parameter controls; patient termination switch; automatic shut-off timer; isolated output circuitry.

Indications for Use

Indicated for patients requiring symptomatic pain relief (chronic, acute post-traumatic, or post-surgical), muscle spasm relaxation, prevention of post-surgical phlebo-thrombosis, increased local blood circulation, prevention/retardation of disuse atrophy, muscle re-education, 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

• Chattanooga's Intelect LV110/LV120 (K861248)
• AMREX' MS322/MS324 (Pre-amendment device)

Submission Summary (Full Text)

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#### SYS*STIM ® 208/208A, MODEL ME 208/208A KO31017 510(K) SUMMARY

| Submitter's Name: | Mettler Electronics Corp. |
|-------------------|----------------------------|
| Address: | 1333 South Claudina Street |
| | Anaheim, CA 92805 |

MAY 3 0 2003

Telephone: [phone]

Robert E. Fleming Contact: Director, QA/RA

March 26, 2002 Date Prepared:

## Device Name:

- a. TRADE NAME:
- b. CLASSIFICATION NAME:
- c. COMMON NAME:

Sys*Stim® 208/208A, Model ME 208/208A Powered Muscle Stimulator Electrical Muscle Stimulator

## Predicate Devices:

| a. TRADE NAME: | Chattanooga's Intelect LV110/LV120<br>AMREX' MS322/MS324 |
|-------------------|----------------------------------------------------------|
| b. 510(k) Number: | K861248<br>Pre-amendment device |

## Description of Device:

## Sys*Stim 208, Model ME 208

The microprocessor controlled Sys*Stim 208 produces low volt current through one channel. The unit produces an asymmetrical electrically balanced waveform. There are three modes of operation: Pulse-1 to 80 Hz, Tetanize-Continuous Output, 80 Hz and Surge-80 Hz, On/Off times variable. The Sys*Stim 208 is portable and beautifully designed. Up and down buttons control the timer while easy-to-use knobs allow you to select treatment parameters and adjust intensity. An optional accessory for the Sys*Stim 208 is the Patient Termination Switch, which is connected to the jack located on back of the unit.

Image /page/0/Picture/16 description: The image shows a device with a screen that displays the number 212. The device has a white border and a dark screen. A cable is connected to the device on the right side.

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# SYS*STIM ® 208/208A, MODEL ME 208/208A 510(K) SUMMARY

#### Sys*Stim 208A, Model ME 208A

The microprocessor controlled Sys*Stim 208A produces low volt current through two channels. The unit produces an asymmetrical electrically balanced waveform. There are four modes of operation: Pulse-1 to 80 Hz, Tetanize-Continuous Output, 80 Hz, Surge-80 Hz, On/Off times variable and Recip-80 Hz, output alternates between the two channels. The Sys*Stim 208A is portable and beautifully designed. Up and down buttons control the timer while easy-to-use knobs allow you to select treatment parameters and adjust intensity. An optional accessory for the Sys+Stim 208A is the Patient Termination Switch, which is connected to the jack located on back of the unit.

Image /page/1/Picture/3 description: The image shows a medical device with a digital display. The device has a white casing and a dark screen. The screen displays the number 22. There is a cable attached to the device.

#### Device Intended Use Statement:

510(k) Number: Device Name: Sys*Stim® 208/208A, Model ME 208/208A

Indications for use:

1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain.

2. Temporary relaxation of muscle spasm.

3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles.

- 4. Increase of blood flow in the treatment area.
- 5. Prevention or retardation of disuse atrophy in post-injury type conditions.
- 6. Muscle re-education.
- 7. Maintaining or increasing range of motion.

KO31017

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K031017

# SYS*STIM®208/208A, MODEL ME 208/208A 510(K) SUMMARY

# Comparison of Technological Characteristics Between Sys*Stim® 208/208A, Model ME 208/208A and Predicate Devices:

| 510 K # | K | K880235 | Pre-amendment |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------|
| Device Name | Sys-Stim 208 | LV-110 | MS322 |
| Manufacturer | Mettler Electronics | Chattanooga | Amrex-Zetron |
| Power Source | 110 V AC, 60 Hz ±10% | 120 V AC, 50/60 Hz | 120 V AC, 60 Hz |
| Number Of Output Modes | 3 | 3 | 3 |
| Channel(S) | 1 | 1 | 1 |
| Synchronous | N/A | N/A | N/A |
| Reciprocal | N/A | N/A | N/A |
| Computerized | No | No | No |
| Software Provided | N/A | N/A | N/A |
| Constant Current | No | Not stated in the manual | Not stated in the manual |
| Constant Voltage | Yes | Not stated in the manual | Not stated in the manual |
| Max Output Current (mA) | 184 mA peak ±20% into 500 Ω<br>72 mA peak ±20% into 2 KΩ<br>17 mA peak ±20% into 10 KΩ | Not Stated in the manual | Not Stated in the manual |
| Max Output Voltage (V) | 92 V peak ±20% into 500 Ω<br>144 V peak ±20% into 2 KΩ<br>166 peak ±20% into 10 KΩ | 110 V peak into 1K ohm<br>load | 110 V peak into 1K ohm<br>load<br>28 V peak into 100 ohm load |
| Waveforms & Channels | | | |
| All Channels | Asymmetrical biphasic with<br>zero net DC | Asymmetrical biphasic with<br>zero net DC | Asymmetrical biphasic with<br>zero net DC |
| Output Displays | No | No | No |
| Channel Isolation | In this system all the outputs<br>are isolated from each other,<br>they have their own<br>amplifiers which are<br>independent from<br>neighboring channels or<br>outputs. The only common<br>thing between the outputs is<br>the microprocessor & the<br>power supply. | Not Stated in the manual | Not Stated in the manual |
| Line Current Isolation | AC power supply is<br>converted to DC Power<br>supply through transformer.<br>Hence there is an insulation<br>of mains from circuitry.<br>From circuitry to output<br>again there is insulation<br>through the transformer,<br>there by double separation<br>between mains and the<br>human body. | Not Stated in the manual | Not Stated in the manual |
| Automatic Overload Trip | No | Not Stated in the manual | Not Stated in the manual |
| Automatic Over Current Trip | No | Not Stated in the manual | Not Stated in the manual |
| Current/Voltage Level | No | Not Stated in the manual | Not Stated in the manual |
| Automatic No Load Trip | No | No | No |
| Automatic Shut-Off | Yes | Yes | Yes |
| Patient Override | Yes | Optional | Optional |
| Control Method | Remote stop | Remote stop | Remote stop |
| Max Leakage Current (µA) | | | |
| Normal | <100 | Not Stated in the manual | <50 |
| Single Fault | <300 | Not Stated in the manual | <50 |
| Indicator Display | | | |
| Unit Functioning | Yes | Yes | Yes |
| Low Battery Indicator | N/A | N/A | N/A |
| Standards | | | |
| UL 544 | No | No | Yes |
| UL 2601-1-UL | No | No | No |
| CUL | No | No | No |
| CSA C22.2 NO 601.1-M90 | No | No | No |
| IEC60601-2-10 | No | No | No |
| EN-55011 (CISPR-11) | No | No | No |
| MDD 93/42/EEC, Annex II | No | No | No |
| Compliance with 21 CFR 898 | Yes | Yes | Yes |
| Timer Settings | 0-60 minutes ±5% | 0-30 minutes | 0- 30 minutes |
| Automatic Shut Off | Yes | Yes | Yes |
| Weight (Ibs.) | 2.25 | 3 | 3 |
| DIMENSIONS (in.) | | | |
| H x W x L | 2.5 (H) x 6 (D) x 8 (L) | 8 (D) x 5.2 (W) x 6.5 (H) | 7.5 (D) x 7.25 (W) x 4.75 (H) |
| Housing Materials | ABS Plastic | Not stated in the manual | Not stated in the manual |
| Construction | Injection Molded | Not stated in the manual | Not stated in the manual |
| III. Alternating Current | | | |
| Type | Biphasic | Biphasic | Alternating |
| Shape | Rectangular | Rectangular | Rectangular |
| Symmetry | Asymmetrical | Asymmetrical | Asymmetrical |
| Net Charge | Zero | Zero | Zero |
| Method | Balanced Waveform | Balanced Waveform | Balanced Waveform |
| Phase Duration Range | + Phase = 200 µs ±10%<br>- Phase = 4 x + Phase ±10% | 200 µs at 50% V max. | 200 µs at 50% V max. |
| Interphase Interval | N/A | N/A | N/A |
| Frequency Range | 1-80 Hz ±10% | 1-80 Hz | 1-80 Hz |
| Tetanize | 80 Hz ±10% | 80 Hz | 80 Hz |
| Maximum Current Density | 0.132 mA/cm² @ 500 Ω | Not stated in the manual | Not stated in the manual |
| Maximum Phase Charge<br>(u Coulombs) | 56 µC ±10% into a 100 ohm load | 56 µC into a 100 ohm load | 56 µC into a 100 ohm load |
| 500 OHMS | 33.5 ±10% | Not stated in the manual | Not stated in the manual |
| 2K OHMS | 13.1 ±10% | Not stated in the manual | Not stated in the manual |
| 10K OHMS | 3.4 ±10% | Not stated in the manual | Not stated in the manual |
| Formula | $q = l x t$ | Not stated in the manual | Not stated in the manual |
| Maximum Power Density | 0.012 W/cm² @ 500 Ω | Not stated in the manual | Not stated in the manual |
| Amplitude Modulation Options<br>Surge | | | |
| Frequency | 80 Hz ±10% | 80 Hz | 80 Hz |
| On Times | 0.375 to 3.75 seconds ±10% | 0.375 to 3.75 seconds | 0.375 to 3.75 seconds |
| Off Times | 0.375 to 3.75 seconds ±10% | 0.375 to 3.75 seconds | 0.375 to 3.75 seconds |
| Modulation Options | | | |
| a) May Be Selected<br>Independently Or<br>Together | N/A | N/A | N/A |
| b) Simultaneously For<br>Each Channel Pair | N/A | N/A | N/A |
| c) Independent Controls<br>For Each Channel | N/A | N/A | N/A |

## ME 208

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# SYS*STIM®208/208A, MODEL ME 208/208A | KO 20 |0 |7
510/17 | 10/2510/K) SUMMARY 510(K) SUMMARY

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# SYS*STIM®208/208A, MODEL ME 208/208A K(03)017 510(K) SUMMARY

Note 1: The Current density and Power density have been calculated using Average Current. Average Current = (Pulse Width / Pulse Frequency ) * Peak Current where Pulse Width and Pulse Frequency is in microseconds Pulse Width = 182 microseconds @ 500 Ohms, Observed on CRO Pulse Frequency = 12500 microseconds (80 Hz - Maximum Frequency)

| equation for maximum phase | Current = ( Output Voltage / 500 Ohms) |
|------------------------------|--------------------------------------------------------------------------------------|
| charge | Phase Charge = Pulse Width x Current (peak to peak) |
| equation for maximum current | Current Density = (Pulse On period / Total Pulse period) x (Voltage /<br>resistance) |
| density | |
| equation for Power Density | Power Density = Current Density x Output Voltage |

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# SYS*STIM®208/208A, MODEL ME 208/208A 510(K) SUMMARY

Image /page/5/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "KO31017". The characters are written in black ink on a white background.

# ME 208A

| 510 K # | K | K880235 | Pre-amendment<br>MS324 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|
| Device Name | Sys*Stim 208A | LV-120 | MS324 |
| Manufacturer | Mettler Electronics | Chattanooga | Amrex-Zetron |
| Power Source | 110 V AC, 60 Hz ±10% | 120 V AC, 50/60 Hz | 120 V AC, 60 Hz |
| Number Of Output Modes | 4 | 4 | 4 |
| Channel(S) | 2 | 2 | 2 |
| Synchronous | Yes | Yes | Yes |
| Reciprocal | Yes | Yes | Yes |
| Computerized | No | No | No |
| Software Provided | N/A | N/A | N/A |
| Constant Current | No | Not stated in the manual | Not stated in the manual |
| Constant Voltage | Yes | Not stated in the manual | Not stated in the manual |
| Max Output Current (mA) | 184 mA peak ±20% into 500 Ω<br>72 mA peak ±20% into 2 ΚΩ<br>17 mA peak ±20% into 10 ΚΩ | Not Stated in the manual | Not Stated in the manual |
| Max Output Voltage (V) | 92 V peak ±20% into 500 Ω<br>144 V peak ±20% into 2 KΩ<br>166 peak ±20% into 10 KΩ | 110 V peak into 1K ohm<br>load<br>28 V peak into 100 ohm load | 110 V peak into 1K ohm<br>load<br>28 V peak into 100 ohm load |
| Waveforms & Channels | | | |
| All Channels | Asymmetrical biphasic with<br>zero net DC | Asymmetrical biphasic with<br>zero net DC | Asymmetrical biphasic with<br>zero net DC |
| Output Displays | No | No | No |
| Channel Isolation | In this system all the outputs<br>are isolated from each other,<br>they have their own<br>amplifiers which are<br>independent from<br>neighboring channels or<br>outputs. The only common<br>thing between the outputs is<br>the microprocessor & the<br>power supply. | Not Stated in the manual | Not Stated in the manual |
| Line Current Isolation | AC power supply is<br>converted to DC Power<br>supply through transformer.<br>Hence there is an insulation<br>of mains from circuitry.<br>From circuitry to output<br>again there is insulation<br>through the transformer,<br>there by double separation<br>between mains and the<br>human body. | Not Stated in the manual | Not Stated in the manual |
| Automatic Overload Trip | No | Not Stated in the manual | Not Stated in the manual |
| Automatic Over Current Trip | No | Not Stated in the manual | Not Stated in the manual |
| Current/Voltage Level | No | Not Stated in the manual | Not Stated in the manual |
| Automatic No Load Trip | No | No | No |
| Automatic Shut-Off | Yes | Yes | Yes |
| | 510(K) SUMMARY | | |
| Patient Override | Yes | Optional | Optional |
| Control Method | Remote stop | Remote stop | Remote stop |
| Max Leakage Current (µA) | | | |
| Normal | <100 | Not Stated in the manual | <50 |
| Single Fault | <300 | Not Stated in the manual | <50 |
| Indicator Display | | | |
| Unit Functioning | Yes | Yes | Yes |
| Low Battery Indicator | N/A | N/A | N/A |
| Standards | | | |
| UL 544 | No | No | Yes |
| UL 2601-1-UL | No | No | No |
| CUL | No | No | No |
| CSA C22.2 NO 601.1-M90 | No | No | No |
| IEC60601-2-10 | N/A | No | No |
| EN-55011 (CISPR-11) | N/A | No | No |
| MDD 93/42/EEC, Annex II | N/A | No | No |
| Compliance with 21 CFR 898 | Yes | Yes | Yes |
| Timer Settings | 0-60 minutes ±5% | 0-30 minutes | 0- 30 minutes |
| Automatic Shut Off | Yes | Yes | Yes |
| Weight (lbs.) | 2.25 | 3 | 3 |
| DIMENSIONS (in.) | | | |
| H x W x L | 2.5 (H) x 6 (D) x 8 (L) | 8 (D) x 5.2 (W) x 6.5 (H) | 7.5 (D) x 7.25 (W) x 4.75 (H) |
| Housing Materials | ABS Plastic | Not stated in the manual | Not stated in the manual |
| Construction | Injection Molded | Not stated in the manual | Not stated in the manual |
| III. Alternating Current | | | |
| Type | Biphasic | Biphasic | Alternating |
| Shape | Rectangular | Rectangular | Rectangular |
| Symmetry | Asymmetrical | Asymmetrical | Asymmetrical |
| Net Charge | Zero | Zero | Zero |
| Method | Balanced Waveform | Balanced Waveform | Balanced Waveform |
| Phase Duration Range | + Phase = 200 µs ±10%<br>- Phase = 4 x + Phase ±10% | 200 µs at 50% V max. | 200 µs at 50% V max. |
| Interphase Interval | N/A | N/A | N/A |
| Frequency Range | 1-80 Hz ±10% | 1-80 Hz | 1-80 Hz |
| Tetanize | 80 Hz ±10% | 80 Hz | 80 Hz |
| Maximum Current Density | 0.132 mA/cm² @ 500 Ω | Not stated in the manual | Not stated in the manual |
| Maximum Phase Charge<br>(u Coulombs) | 56 µC ±10% into a 100 ohm load | 56 µC into a 100 ohm load | 56 µC into a 100 ohm load |
| 500 OHMS | 33.5 ±10% | Not stated in the manual | Not stated in the manual |
| 2K OHMS | 13.1 ±10% | Not stated in the manual | Not stated in the manual |
| | 510(K) SUMMARY | | |
| 10K OHMS | 3.4 ±10% | Not stated in the manual | Not stated in the manual |
| Formula | $q = I \times t$ | Not stated in the manual | Not stated in the manual |
| Maximum Power Density | 0.012 W/cm² @ 500 Ω | Not stated in the manual | Not stated in the manual |
| Amplitude Modulation Options | | | |
| Surge | | | |
| Frequency | 80 Hz ±10% | 80 Hz | 80 Hz |
| On Times | 0.375 to 3.75 seconds ±10% | 0.375 to 3.75 seconds | 0.375 to 3.75 seconds |
| Off Times | 0.375 to 3.75 seconds ±10% | 0.375 to 3.75 seconds | 0.375 to 3.75 seconds |
| Recip | | | |
| Frequency | 80 Hz ±10% | 80 Hz | 80 Hz |
| On Times | 0.375 to 3.75 seconds ±10% | 0.375 to 3.75 seconds | 0.375 to 3.75 seconds |
| Off Times | 0.375 to 3.75 seconds ±10% | 0.375 to 3.75 seconds | 0.375 to 3.75 seconds |
| Modulation Options | | | |
| a) May Be Selected<br>Independently Or<br>Together | N/A | N/A | N/A |
| b) Simultaneously For<br>Each Channel Pair | N/A | N/A | N/A |
| c) Independent Controls<br>For Each Channel | N/A | N/A | N/A |

Image /page/5/Picture/6 description: The image shows a black and white abstract shape. The shape is located in the upper right corner of the image. The shape is irregular and has a rough texture.

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# SYS*STIM ® 208/208A, MODEL ME 208/208A | KOZ/O/7

.

:

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# SYS*STIM ® 208/208A, MODEL ME 208/208A XO3/077 510(K) SUMMARY

Note 1: The Current density and Power density have been calculated using Average Current. Average Current = (Pulse Width / Pulse Frequency ) * Peak Current where Pulse Width and Pulse Frequency is in microseconds Pulse Width = 182 microseconds @ 500 Ohms, Observed on CRO Pulse Frequency = 12500 microseconds (80 Hz - Maximum Frequency)

| equation for maximum phase | Current = (Output Voltage / 500 Ohms) |
|------------------------------|-----------------------------------------------------------------------------------|
| charge | Phase Charge = Pulse Width x Current (peak to peak) |
| equation for maximum current | Current Density = (Pulse On period / Total Pulse period) x (Voltage / resistance) |
| density | |
| equation for Power Density | Power Density = Current Density x Output Voltage |

ﺮ ﺍﻟﻤﺮﺍﺟﻊ ..;

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle's head with three stripes representing the feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Public Health Service

MAY 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert E. Fleming Director, QA/RA Official Correspondent Mettler Electronics Corp. 1333 South Claudina Street Anaheim, California 92805

Re: K031017 Trade/Device Name: Sys*Stim® 208 and 208A Regulation Number: 21 CFR 882.5890, 890.5850 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator Regulatory Class: II Product Code: IPF, GZJ Dated: March 28, 2003 Received: March 31, 2003

Dear Mr. Fleming:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is s…