(60 days)
No
The description mentions a "microprocessor controlled" device with selectable modes and adjustable parameters via knobs and buttons. There is no mention of AI, ML, or any adaptive or learning capabilities based on data input.
Yes
The 'Intended Use / Indications for Use' section lists several pain relief, muscle relaxation, and rehabilitation purposes.
No
The Intended Use / Indications for Use describe therapeutic applications like pain relief, muscle relaxation, blood flow increase, and muscle re-education, not diagnosis. The Device Description details how it produces low volt current for treatment, not for obtaining diagnostic information.
No
The device description explicitly details physical hardware components, including a microprocessor-controlled unit, knobs, buttons, and an optional patient termination switch, which are not characteristic of a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description and intended uses of the Sys*Stim 208 and 208A clearly indicate that they are devices that apply electrical stimulation to the body for therapeutic purposes (pain relief, muscle stimulation, etc.). They do not involve the analysis of bodily specimens.
Therefore, the Sys*Stim 208 and 208A are therapeutic devices, not IVDs.
N/A
Intended Use / Indications for Use
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.
Also listed as:
- 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
Product codes
IPF, GZJ
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K861248, Pre-amendment device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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/LV120
AMREX' MS322/MS324 |
|-------------------|----------------------------------------------------------|
| b. 510(k) Number: | K861248
Pre-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 Ω | ||
| 72 mA peak ±20% into 2 KΩ | |||
| 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 | ||
| 144 V peak ±20% into 2 KΩ | |||
| 166 peak ±20% into 10 KΩ | 110 V peak into 1K ohm | ||
| load | 110 V peak into 1K ohm | ||
| load | |||
| 28 V peak into 100 ohm load | |||
| Waveforms & Channels | |||
| All Channels | Asymmetrical biphasic with | ||
| zero net DC | Asymmetrical biphasic with | ||
| zero net DC | Asymmetrical biphasic with | ||
| zero net DC | |||
| Output Displays | No | No | No |
| Channel Isolation | In this system all the outputs | ||
| are isolated from each other, | |||
| they have their own | |||
| amplifiers which are | |||
| independent from | |||
| neighboring channels or | |||
| outputs. The only common | |||
| thing between the outputs is | |||
| the microprocessor & the | |||
| power supply. | Not Stated in the manual | Not Stated in the manual | |
| Line Current Isolation | AC power supply is | ||
| converted to DC Power | |||
| supply through transformer. | |||
| Hence there is an insulation | |||
| of mains from circuitry. | |||
| From circuitry to output | |||
| again there is insulation | |||
| through the transformer, | |||
| there by double separation | |||
| between mains and the | |||
| 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 | |||
| (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)