(60 days)
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
- Temporary relaxation of muscle spasm
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- Increase of blood flow in the treatment area.
- Prevention or retardation of disuse atrophy in post-injury type conditions.
- Muscle re-education.
- Maintaining or increasing range of motion.
SysStim 208, Model ME 208: The microprocessor controlled SysStim 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 SysStim 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 SysStim 208 is the Patient Termination Switch, which is connected to the jack located on back of the unit.
SysStim 208A, Model ME 208A: The microprocessor controlled SysStim 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.
The provided 510(k) summary for the Sys*Stim® 208/208A, Model ME 208/208A does not describe acceptance criteria or a study to prove the device meets acceptance criteria.
The document is a "510(k) Summary" which serves to demonstrate substantial equivalence to previously cleared predicate devices. It provides a detailed comparison of the technological characteristics of the Sys*Stim® 208/208A with its predicate devices (Chattanooga's Intelect LV110/LV120 and AMREX' MS322/MS324). This comparison serves as the basis for the FDA's determination of substantial equivalence, meaning that the new device is as safe and effective as the predicate device(s) and does not raise new questions of safety or effectiveness.
Therefore, I cannot populate the requested table or answer most of the questions, as the information is not present in the provided text.
Here's a breakdown of what can be inferred or directly stated from the document, and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a study. Instead, the document presents the specifications of the new device and compares them to predicate devices, implying that matching or being within acceptable ranges of the predicate device specifications is the "acceptance" for substantial equivalence.
- Reported Device Performance: The document lists the technical specifications and operational parameters of the Sys*Stim® 208/208A. These are not "reported performance" from a study but rather the design specifications of the device.
| Characteristic | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (Sys*Stim® 208/208A) |
|---|---|---|
| Power Source | Similar to predicate devices (110-120V AC, 50/60 Hz) | 110 V AC, 60 Hz ±10% |
| Number Of Output Modes | Similar to predicate devices (3 for 208, 4 for 208A) | SysStim 208: 3; SysStim 208A: 4 |
| Channels | Similar to predicate devices (1 for 208, 2 for 208A) | SysStim 208: 1; SysStim 208A: 2 |
| Waveform & Channels | Asymmetrical biphasic with zero net DC | Asymmetrical biphasic with zero net DC |
| Max Output Current (mA) | Not explicitly stated for predicates, but implied similar operating range | 184 mA peak ±20% into 500 Ω; 72 mA peak ±20% into 2 KΩ; 17 mA peak ±20% into 10 KΩ |
| Max Output Voltage (V) | Similar to predicate devices (e.g., 110 V peak into 1K ohm load) | 92 V peak ±20% into 500 Ω; 144 V peak ±20% into 2 KΩ; 166 peak ±20% into 10 KΩ (Sys*Stim 208/208A) |
| Max Leakage Current (µA) | Normal <50 (MS322/MS324); Single Fault <50 (MS322/MS324) | Normal <100; Single Fault <300 (Within acceptable safety limits, possibly broader than some predicates but considered equivalent) |
| Timer Settings | 0-30 minutes | 0-60 minutes ±5% (This is an improvement/difference but still considered substantially equivalent for the intended use) |
| Phase Duration Range | 200 µs at 50% V max. (for predicates) | + Phase = 200 µs ±10%; - Phase = 4 x + Phase ±10% |
| Frequency Range | 1-80 Hz | 1-80 Hz ±10% |
| Maximum Phase Charge | 56 µC into a 100 ohm load | 56 µC ±10% into a 100 ohm load; 33.5 ±10% for 500 Ω; 13.1 ±10% for 2 KΩ; 3.4 ±10% for 10 KΩ |
| Maximum Current Density | Not stated in predicate manuals | 0.132 mA/cm² @ 500 Ω |
| Maximum Power Density | Not stated in predicate manuals | 0.012 W/cm² @ 500 Ω |
| Automatic Shut-Off | Yes | Yes |
| Patient Override | Optional | Yes |
| Compliance with 21 CFR 898 | Yes | Yes |
| Indications for Use | Matched to predicate devices for powered muscle stimulators and transcutaneous electrical nerve stimulators. | 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. |
Missing Information (Not described in the provided document):
2. Sample size used for the test set and the data provenance: Not applicable. This document is a technical comparison for substantial equivalence, not a clinical or performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrical muscle stimulator, not an AI-assisted diagnostic tool or imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission is implicitly the established performance and safety of the predicate devices.
8. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is a medical device clearance, not an AI/machine learning model submission.
9. How the ground truth for the training set was established: Not applicable.
Summary of the Study (as described in the document):
The document does not describe a "study" in the traditional sense of a clinical trial or performance evaluation with specific acceptance criteria. Instead, it presents a technical comparison and declaration of substantial equivalence. The "study" is the comparison made between the Sys*Stim® 208/208A and its legally marketed predicate devices (Chattanooga's Intelect LV110/LV120 and AMREX' MS322/MS324). Mettler Electronics Corp. asserts that their devices are substantially equivalent to these predicates based on similar intended use, technological characteristics (waveform, output modes, power, timer settings, safety features like automatic shut-off and patient override), and compliance with relevant regulations (21 CFR 898).
The detailed tables comparing the specifications of the new device to the predicates serve as the evidence to "prove the device meets acceptance criteria" for regulatory clearance based on substantial equivalence. The acceptance criteria are implicitly that the new device's specifications and performance must be sufficiently similar to the predicate devices and not raise new questions of safety or effectiveness.
{0}------------------------------------------------
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: 714-533-2221
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/LV120AMREX' MS322/MS324 |
|---|---|
| b. 510(k) Number: | K861248Pre-amendment device |
Description of Device:
Sys*Stim 208, Model ME 208
The microprocessor controlled SysStim 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 SysStim 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.
{1}------------------------------------------------
SYS*STIM ® 208/208A, MODEL ME 208/208A 510(K) SUMMARY
Sys*Stim 208A, Model ME 208A
The microprocessor controlled SysStim 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 SysStim 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:
-
Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain.
-
Temporary relaxation of muscle spasm.
-
Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles.
-
- Increase of blood flow in the treatment area.
-
- Prevention or retardation of disuse atrophy in post-injury type conditions.
-
- Muscle re-education.
-
- Maintaining or increasing range of motion.
KO31017
{2}------------------------------------------------
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 Ω72 mA peak ±20% into 2 KΩ17 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 Ω144 V peak ±20% into 2 KΩ166 peak ±20% into 10 KΩ | 110 V peak into 1K ohmload | 110 V peak into 1K ohmload28 V peak into 100 ohm load |
| Waveforms & Channels | |||
| All Channels | Asymmetrical biphasic withzero net DC | Asymmetrical biphasic withzero net DC | Asymmetrical biphasic withzero net DC |
| Output Displays | No | No | No |
| Channel Isolation | In this system all the outputsare isolated from each other,they have their ownamplifiers which areindependent fromneighboring channels oroutputs. The only commonthing between the outputs isthe microprocessor & thepower supply. | Not Stated in the manual | Not Stated in the manual |
| Line Current Isolation | AC power supply isconverted to DC Powersupply through transformer.Hence there is an insulationof mains from circuitry.From circuitry to outputagain there is insulationthrough the transformer,there by double separationbetween mains and thehuman 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%- 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(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 OptionsSurge | |||
| 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 SelectedIndependently OrTogether | N/A | N/A | N/A |
| b) Simultaneously ForEach Channel Pair | N/A | N/A | N/A |
| c) Independent ControlsFor Each Channel | N/A | N/A | N/A |
ME 208
{3}------------------------------------------------
SYS*STIM®208/208A, MODEL ME 208/208A | KO 20 |0 |7
510/17 | 10/2510/K) SUMMARY 510(K) SUMMARY
{4}------------------------------------------------
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 /resistance) |
| density | |
| equation for Power Density | Power Density = Current Density x Output Voltage |
{5}------------------------------------------------
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-amendmentMS324 |
|---|---|---|---|
| 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 Ω72 mA peak ±20% into 2 ΚΩ17 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 Ω144 V peak ±20% into 2 KΩ166 peak ±20% into 10 KΩ | 110 V peak into 1K ohmload28 V peak into 100 ohm load | 110 V peak into 1K ohmload28 V peak into 100 ohm load |
| Waveforms & Channels | |||
| All Channels | Asymmetrical biphasic withzero net DC | Asymmetrical biphasic withzero net DC | Asymmetrical biphasic withzero net DC |
| Output Displays | No | No | No |
| Channel Isolation | In this system all the outputsare isolated from each other,they have their ownamplifiers which areindependent fromneighboring channels oroutputs. The only commonthing between the outputs isthe microprocessor & thepower supply. | Not Stated in the manual | Not Stated in the manual |
| Line Current Isolation | AC power supply isconverted to DC Powersupply through transformer.Hence there is an insulationof mains from circuitry.From circuitry to outputagain there is insulationthrough the transformer,there by double separationbetween mains and thehuman 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%- 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(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 SelectedIndependently OrTogether | N/A | N/A | N/A |
| b) Simultaneously ForEach Channel Pair | N/A | N/A | N/A |
| c) Independent ControlsFor 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.
{6}------------------------------------------------
SYS*STIM ® 208/208A, MODEL ME 208/208A | KOZ/O/7
.
:
{7}------------------------------------------------
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 ..;
{8}------------------------------------------------
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 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. Iisting 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
{9}------------------------------------------------
Page 2 - Mr. Robert E. Fleming
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 merketing your device as described in your Section 510(k) 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milken
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
{10}------------------------------------------------
Attachment 1 b
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
-
- Temporary relaxation of muscle spasm
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
-
- Increasing local blood circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrent of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative and Neurological Devices |
| 510(k) Number | K031017 |
|---|---|
| Prescription Use | |
| (Per 21 CFR 801.109) | |
| OR | Over-The-Counter Use |
{11}------------------------------------------------
Attachment 1 b
Page_ of
510(k) Number (if known): K031017
Device Name: Sys*Stim 208A (ME208A)
Indications For Use:
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
-
- Temporary relaxation of muscle spasm
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
-
- Increasing local blood circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrent of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K031017
OR Over-The-Counter Use
Prescription Use
(Per 21 CFR 801.109)
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).