(278 days)
No
The device description details fixed, pre-set stimulation programs with no mention of adaptive algorithms, learning, or data processing beyond basic electrical signal generation and control. The controls are limited to program selection, intensity, and duration, which are not indicative of AI/ML functionality.
Yes
The device description and intended use clearly state that the SWISSSTIM is used for therapeutic purposes, including muscle re-education, pain relief, prevention of muscle disuse atrophy, and improving range of motion.
No
The device is described as an electro-stimulation device used for therapeutic purposes such as preventing muscle disuse atrophy, relaxing muscle spasms, increasing blood circulation, muscle re-education, and pain relief. It does not perform any diagnostic functions like detecting or identifying a disease or condition. The "Key Metrics" section explicitly states "Not Applicable (Electro-stimulation device, not a diagnostic device)".
No
The device description clearly states it is a battery-powered device with physical components like channels, intensity controls, a plastic enclosure, output cables, batteries, and electrodes. It delivers electrical stimulation pulses, which is a hardware function.
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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The SWISSSTIM is an electro-stimulation device that applies electrical impulses to the skin for therapeutic purposes (muscle stimulation and pain relief). It does not analyze any biological specimens.
- Intended Use: The stated indications for use are all related to therapeutic treatment and management of physical conditions, not diagnosis.
Therefore, the SWISSSTIM falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indications for EMS use are:
- Prevention or retardation of muscle disuse atrophy
- Relaxation of muscle spasms
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or improving range of motion of extremities
Indications for TENS use are:
- Symptomatic relief and management of chronic, intractable pain, and
- Adjunctive treatment for post-surgical and post-trauma acute pain
Product codes
IPF, GZJ
Device Description
SWISSSTIM is a battery-powered device for transcutaneous nerve and neuromuscular electro-stimulation. It has two channels (outputs) of stimulation, each with independent intensity control. The unit delivers synchronous, low voltage stimulation impulses at both of its outputs. The stimulation output voltage waveforms are in form of trains of monophasic, rectangular impulses. Such waveform character is true, when the outputs are connected to any resistor in a range from 100 ohms to 10,000 ohms.
The EMS mode of this device has four different stimulation programs. The medical professional or patient under medical supervision can select any of these four stimulation programs, as appropriate for their treatment objectives. For each stimulation program, the medical professional or patient selects the desired phases of the stimulation programs as well as the stimulation duration; the impulse frequencies and impulse durations are different and all are preset at the factory.
There are no user accessible controls that can change either the frequency or impulse duration during a treatment. The user accessible controls are the ON/OFF button, the SELECT button and the two (2) buttons that control menu access and intensity levels for the 2 independent channels. The stimulus is a low voltage, low frequency, rectangular waveform.
The TENS mode of this device has ten (10) programs. The TENS mode is what has been added to this device and therefore modifies the Indications for Use from the predicate device, K022175. The TENS mode is controlled in the same fashion as the EMS mode of the SWISSSTIM.
The device is housed in a plastic enclosure and is powered by four (4) AAA batteries. Accessories include output cables, batteries, User's Manual, storage case and electrodes. There is no provision for an AC adapter and the unit cannot be connected to any AC electrical power circuit.
From a technical perspective, the SWISSSTM delivers stimulation pulses of 50V (peak value) +/- 10% onto 500 ohms at maximum settings, which corresponds to 100 mA (peak value) current intensity. The impulse frequencies produced by the device are in a range of 1 Hz to 120 Hz, depending on the choice of stimulation program. The voltage waveforms are rectangular monophasic with duration time from 20 us to 1000 us. The current impulses are monophasic on 500 ohms load. The tetanization stimulation signal includes ramp, which slowly increases the contraction intensity during treatments.
The EMS function is used as a therapeutic tool, specifically for rehabilitation purposes as noted in the Indications for Use (please see Section B). An example is prevention of disuse muscle atrophy that may occur after musculoskeletal injuries such as damage to bones, joints, muscles, ligaments and tendons. The TENS functions address pain mitigation, whether chronic or acute pain; TENS is a non-invasive, safe nerve stimulation intended to reduce such pain. A number of systematic reviews or metaanalyses have confirmed TENS effectiveness for postoperative pain, osteoarthritis, and chronic musculoskeletal pain.
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
medical professional or patient under medical supervision
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)
Non-Clinical Performance Data: The SWISSSTIM device was analyzed in accordance with the AAMI/ANSI standard "AAMI NS4:1986/(R)2009: AAMI Standard for Transcutaneous Electrical Nerve Stimulators" Electrode/Skin Impedance Model (ESIM).
Electromagnetic Compatibility and Electrical Safety: FDA recommended testing has been completed.
- Emission: EN 55011, EN 60601-1-2/EN 60601-2-10, Result: Pass
- Immunity to Electrical Discharge: EN 61000-4-2, EN 60601-1-2/EN 60601-2-10, Result: Pass
- Immunity to Radiated rf/emf: EN 61000-4-3, EN 60601-1-2/EN 60601-2-10, Result: Pass
- Immunity to Conducted Disturbances Induced by rf Fields: EN 61000-4-6, EN 60601-1-2/EN 60601-2-10, Result: Pass
- Immunity to Power Frequency Magnetic Field: EN 61000-4-8, EN 60601-1-2/EN 60601-2-10, Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P4-PHYSIO (K022175), Styline 882 (K092448)
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
APR 3 0 2012
'age
· Prevention or retardation of muscle disuse atrophy
- Relaxation of muscle spasms
- Increasing local blood circulation
- Muscle re-education
-
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or improving range of motion of extremities
Indications for TENS use are:
-
Symptomatic relief and management of chronic, intractable pain, and
-
Adjunctive treatment for post-surgical and post-trauma acute pain
11. Device Summary
SWISSsme is a battery-powered device for transcutaneous nerve and neuromuscular electro-stimulation. It has two channels (outputs) of stimulation, each with independent intensity control. The unit delivers synchronous, low voltage stimulation impulses at both of its outputs. The stimulation output voltage waveforms are in form of trains of monophasic, rectanqular impulses. Such waveform character is true, when the outputs are connected to anv resistor in a range from 100 Ω to 10,000 Ω.
The EMS mode of this device has four different stimulation programs. The medical professional or patient under medical supervision can select any of these four stimulation programs, as appropriate for their treatment objectives. For each stimulation program, the medical professional or patient selects the desired phases of the stimulation programs as well as the stimulation duration; the impulse frequencies and impulse durations are different and all are preset at the factory.
There are no user accessible controls that can change either the frequency or impulse duration during a treatment. The user accessible controls are the ON/OFF button, the SELECT button and the two (2) buttons that control menu access and intensity levels for the 2 independent channels. The stimulus is a low voltage, low frequency, rectangular waveform.
The TENS mode of this device has ten (10) programs. The TENS mode is what has been added to this device and therefore modifies the Indications for Use from the predicate device, K022175. The TENS mode is controlled in the same fashion as the EMS mode of the SWISSSTIM.
2
The device is housed in a plastic enclosure and is powered by four (4) AAA batteries. Accessories include output cables, batteries, User's Manual, storage case and electrodes. There is no provision for an AC adapter and the unit cannot be connected to any AC electrical power circuit.
From a technical perspective, the SWISSsma delivers stimulation pulses of 50v (peak value) ± 10% onto 500Ω at maximum settings, which corresponds to 100 mA (peak value) current intensity. The impulse frequencies produced by the device are in a range of 1 Hz to 120 Hz, depending on the choice of stimulation program. The voltage waveforms are rectangular monophasic with duration time from 20 us to 1000 us. The current impulses are monophasic on 500 Ω load. The tetanization stimulation signal includes ramp, which slowly increases the contraction intensity during treatments.
The EMS function is used as a therapeutic tool, specifically for rehabilitation purposes as noted in the Indications for Use (please see Section B). An example is prevention of disuse muscle atrophy that may occur after musculoskeletal injuries such as damage to bones, joints, muscles, ligaments and tendons. The TENS functions address pain mitigation, whether chronic or acute pain; TENS is a non-invasive, safe nerve stimulation intended to reduce such pain. A number of systematic reviews or metaanalyses have confirmed TENS effectiveness for postoperative pain, osteoarthritis, and chronic musculoskeletal pain.
12. Technological Summary
The SWISS TIM technical characteristics are similar to the predicate devices in design. materials and energy source. A summary of these characteristics is provided below:
Image /page/2/Figure/6 description: The image shows an oscilloscope display with a waveform. The waveform shows a voltage signal that is initially high, then drops to a lower level. The x-axis is labeled "M 100us", indicating a time scale of 100 microseconds per division, and the y-axis is labeled "20.0U/DIV", indicating a voltage scale of 20 volts per division. There are also some menu options on the right side of the screen.
SwissStim Voltage IVI
Load: 500 ohms
Image /page/2/Figure/8 description: The image shows an oscilloscope display with a waveform. The waveform has a sharp rise, a slight decay, and then a sharp drop, followed by a flat line. The vertical scale is 20.0U/DIV, and the horizontal scale is M 100 μs, indicating the voltage and time scales of the waveform.
P4 Physio Voltage [V]
3
K112148 PAGE 4 OF 12
Image /page/3/Figure/1 description: The image shows four graphs, each displaying data from a LeCroy device. The top left graph is labeled "Hivex Stiline Voltage [V]", while the top right graph is labeled "Comparison of All Devices". The bottom left graph is labeled "SwissStim Current [mA]", and the bottom right graph is labeled "P4 Physio Current". All four graphs have a similar grid layout and display waveforms, with a scale of 20.0U/DIV and M 100μs.
Hivox Styline Voltage [V]
Hivox Styline Current [mA]
M 1991
50mA/DIU
Image /page/3/Figure/16 description: The image shows an oscilloscope display with a single pulse waveform. The waveform transitions from a low state to a high state and then returns to the low state. The horizontal scale is labeled as "M 100us", indicating a time scale of 100 microseconds per division, while the vertical scale is labeled as "50mA/DIV", indicating a current scale of 50 milliamperes per division. The oscilloscope is a LeCroy brand.
SwissStim Voltage [V]
Image /page/3/Figure/5 description: The image shows an oscilloscope display with a square wave signal. The vertical scale is set to 20.0V/DIV, and the horizontal scale is set to M 100μs. The square wave transitions from a low voltage level to a high voltage level and then back down, indicating a pulse or switching event. The right side of the image shows menu options such as Type, Image, Touche Imo, and Enredistre.
Comparison of All Devices Voltage [V]
Image /page/3/Figure/7 description: The image shows an oscilloscope display with a graph plotted on it. The graph shows a signal that rapidly rises to a high level, remains there for a short period, and then quickly drops to a lower level. The display also shows text labels such as "Type", "Image", "Enr.Image", and "Enregistrer", along with the settings "20.0U/DIV" and "M 100μs".
P4 Physio Current [mA]
Image /page/3/Figure/9 description: The image shows a screenshot of an oscilloscope display. A square wave is displayed on the grid, showing a transition from a low to a high state and then back to a low state. The vertical scale is labeled as 50mA/DIV, and the horizontal scale is labeled as M 100us. The right side of the image shows a menu with options such as "Type", "Image", and "Enregistrer".
Comparison of All Devices Current [mA]
Image /page/3/Figure/11 description: The image shows a graph with a square wave. The x-axis is labeled "M 100us" and the y-axis is labeled "50mA/DIV". The square wave starts at 0, rises to approximately 200mA, stays there for about 200us, and then drops back to 0.
Load: 2000 ohms
P4 Physio Voltage [V]
Image /page/3/Figure/14 description: The image shows an oscilloscope display. The display shows a waveform with a sharp rise and fall, followed by a period of relatively constant voltage. The text on the screen indicates that the vertical scale is 20.0U/DIV and the horizontal scale is M 100μs. There are also menu options visible on the right side of the screen, including "Type Image", "Touche.Impr", and "Enregistrer".
4
Hivox Styline Voltage [V]
Image /page/4/Figure/2 description: The image shows an oscilloscope display with a square wave signal. The signal transitions from a high voltage level to a low voltage level. The vertical scale is set to 20.0V per division, and the horizontal scale is set to 100 microseconds per division. The image also shows a menu on the right side with options such as 'Type', 'Image', and 'Enregistrer'.
SwissStim Current [mA]
| Image: LeCroy logo and icons | |||
|---|---|---|---|
| Type | |||
| Image | |||
| Touche.Impr | |||
| Enr.Image | |||
| Enregistrer | |||
| 50mA/DIV | M 100μs |
Hivox Styline Current [mA]
Image /page/4/Figure/6 description: The image shows a screenshot of an oscilloscope display. The display shows a single waveform that transitions from a low level to a high level and then back to a low level. The horizontal scale is labeled as "M 100us", indicating a time scale of 100 microseconds per division, and the vertical scale is labeled as "50mA/DIV", indicating a current scale of 50 milliamperes per division.
Comparison of All Devices Voltage [V]
Image /page/4/Figure/8 description: The image shows an oscilloscope display with a graph plotted on it. The text on the screen indicates settings of "20.0U/DIV" and "M 100ps", suggesting the vertical scale is 20 units per division and the horizontal scale is 100 microseconds. On the right side of the screen, there is a menu with options like "Type", "Image", "Touche Imp", and "Enr.Image".
P4 Physio Current [mA]) Type lmage Touche Imp Enrimade Enteristie 50mA/DIU M 100 ps
Comparison of All Devices
Current [mA]
Image /page/4/Figure/12 description: The image shows a graph with a horizontal line that has a step change. The x-axis is labeled "M 100μs", and the y-axis is labeled "50mA/DIV". On the right side of the image, there is a menu with the options "Type", "Image", "Touche Impr", and "Enriman". The graph shows a signal that is initially at a higher level, then drops to a lower level.
5
K112148 PAGE 6 OF 12
Load: 10000 ohms
SwissStim Voltage [V]
Image /page/5/Figure/3 description: The image shows an oscilloscope display with a square wave signal. The vertical scale is set to 20.0V/DIV, and the horizontal scale is set to M 100 us. The signal transitions from a low state to a high state and then back to a low state. The LeCroy logo is visible in the upper left corner of the display.
Hivox Styline Voltage [V]
| 1200 @ hummunum | |||||
|---|---|---|---|---|---|
| Type | |||||
| · Image | |||||
| Touche Impr | |||||
| Enr.Image | |||||
| Enregistrer | |||||
| 20.90/DIU | M 188ps |
SwissStim Current [mA]
Image /page/5/Figure/7 description: The image shows an oscilloscope display with a signal trace. The signal appears to be a square wave with some noise present. The vertical scale is labeled as 5mA/DIV, and the horizontal scale is labeled as M 100us. There are also some menu options visible on the right side of the screen, including 'Type', 'Image', and 'Enregistrer'.
P4 Physio Voltage [V]
Image /page/5/Figure/9 description: The image shows an oscilloscope display with a waveform. The oscilloscope is a LeCroy model. The vertical scale is set to 20.0U/DIV, and the horizontal scale is set to M 100 μs.
Comparison of All Devices Voltage [V]
Image /page/5/Figure/11 description: The image shows a screenshot of an oscilloscope display. Two waveforms, labeled 1.1.1 and 1.1.2, are displayed on the grid. The vertical scale is set to 20.0V/DIV, and the horizontal scale is set to M 100μs.
Image /page/5/Figure/12 description: The image shows a graph of P4 Physio Current in mA. The graph shows a square wave with a period of approximately 200 microseconds. The y-axis is labeled 5mA/DIV, and the x-axis is labeled M 100ps. There is a menu on the right side of the image with options such as Type, Image, and Touche Imp.
P4 Physio Current [mA]
6
KII2148 PAGE 7 OF 12
Image /page/6/Figure/1 description: The image shows a graph of the Hivox Styline Current in milliamperes. The graph is displayed on a LeCroy oscilloscope. The x-axis is labeled as M 100us, and the y-axis is labeled as 5mA/DIV. The graph shows a current signal that is initially at a low level, then increases to a higher level for a short period of time, and then returns to the low level.
Comparison of All Devices Current [mA]
Image /page/6/Figure/3 description: The image shows a graph with a line plot. The x-axis is labeled "M 100μs", and the y-axis is labeled "5mA/DIV". The graph shows a signal that rises sharply, plateaus for a short time, and then drops sharply again. There is also a menu on the right side of the image with options such as "Type", "Image", and "Enr.Image".
Other characteristics such as Indications for Use, safety, efficacy and operational parameters of the predicate devices and the SWISS TIM are shown below.
| Critical Parameter Comparison Table | |||
|---|---|---|---|
| Parameter | SWISSSTIM | Styline 882 | P4 Physio |
| K112148 | K092448 | K022175 | |
| Indications | |||
| for Use | EMS: |
Prevention or
retardation of
muscle disuse
atrophy
Relaxation of
muscle spasms
Increasing local
blood circulation
Muscle re-
education
Immediate post-
surgical stimulation
of calf muscles to
prevent venous
thrombosis
Maintaining or
improving range of
motion of
extremities | EMS:
Prevention or
retardation of
muscle disuse
atrophy
Relaxation of
muscle spasms
Increasing local
blood circulation
Muscle re-
education and
strengthening
Immediate post-
surgical stimulation
of calf muscles to
prevent venous
thrombosis
Maintaining or
improving range of
motion of
extremities | EMS:
Prevention or
retardation of
muscle disuse
atrophy
Relaxation of
muscle spasms
Increasing local
blood circulation
Muscle re-
education and
strengthening
Immediate post-
surgical stimulation
of calf muscles to
prevent venous
thrombosis
Maintaining or
improving range of
motion of
extremities |
| | TENS:
Symptomatic relief
and management
of chronic,
intractable pain,
and
Adjunctive
treatment for post-
surgical and post- | TENS:
Symptomatic relief
and management
of chronic,
intractable pain,
and
Adjunctive
treatment for post- | |
| | trauma acute pain | | |
| Safety | 1- Complies with
ISO 9001/2000 and
ISO 13485/2003,
International Quality
Standard, IEC-601-
2-10 European
Safety Standard
and in compliance
with all EC medical
device directives
applicable to Class
IIA medical devices.
2 - Automatic
limitation of
stimulation current
density
3 - Embedded
programs cannot be
changed; users can
only modify the
intensity of
stimulation
4 - All programs
begin with minimal
electrical intensity;
the medical
professional or
patient must
increase the
intensity to desired
treatment level
5 - Maximum
electrical impulse
charge is 50 micro-
coulombs
6 - Automatic
stimulation current
density control
precludes excessive
current density at
the electrode-skin
interface, ensuring
skin safety
7- Lead cables
preclude the
possibility of
accidental
connection to a
power source such | 1- Complies with
ISO 9001/2000 and
ISO 13485/2003,
International Quality
Standard, IEC-601-
2-10 European
Safety Standard
and in compliance
with all EC medical
device directives
applicable to Class
IIA medical devices.
2 - No automatic
limitation of
stimulation current
density
3 - Users can
design individual
programs as well as
modify the intensity
of stimulation
4 - All programs
begin with minimal
electrical intensity;
the medical
professional or
patient must
increase the
intensity to desired
treatment level
5 - Maximum
electrical impulse
charge is not
provided
6 - No automatic
stimulation current
density control
7- Lead cables
preclude the
possibility of
accidental
connection to a
power source such
as an AC power
outlet
8 - Specific
warnings and
contraindications in
User Manual | 1- Complies with
ISO 9001/2000 and
ISO 13485/2003,
International Quality
Standard, IEC-601-
2-10 European
Safety Standard
and in compliance
with all EC medical
device directives
applicable to Class
IIA medical devices.
2 - Automatic
limitation of
stimulation current
density
3 - Embedded
programs can not
be changed; users
can only modify the
intensity of
stimulation
4 - All programs
begin with minimal
electrical intensity:
the medical
professional or
patient must
increase the
intensity to desired
treatment level
5 - Maximum
electrical impulse
charge is 23 micro-
coulombs
6 - Automatic
stimulation current
density control
precludes excessive
current density at
the electrode-skin
interface, ensuring
skin safety
7- Lead cables
preclude the
possibility of
accidental
connection to a
power source such |
Page 7
7
K112148
PAGE 8 OF 12
း
వ
网
Page 8
8
KI1214 PAGE 9 OF 12
| Efficacy | The EMS programs
are substantially
equivalent to the
EMS programs in
the P4 Physio.
The 10 TENS
programs are
designed to parallel
the TENS programs
in the predicate
device. There are
variations but these
relate to stimulation
patterns rather than
frequency ranges. | There are 10 EMS
and 10 TENS
programs | FDA cleared with 4
EMS programs that
have six (6)
Indications for Use,
including:
• 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 |
|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operation | Ease of Use: Only
selection of
programs, phases
and intensity levels
are possible;
intensity levels are
set independently
for each channel.
Pre-treatment
preparation and
post-treatment
instructions are the
same as those for
both predicate
devices. | Ease of Use: User's
have additional
options and can
select not only
programs and
intensity levels but
also program
duration time and
pulse rates (HZ).
These features
make this predicate
device more
complex to operate. | Ease of Use: Only
selection of
programs, phases
and intensity levels
are possible. |
13. Non-Clinical Performance Data
The SWISSsm device (and predicate devices) have also been analyzed in accordance with the AAMI/ANSI standard "AAMI NS4:1986/(R)2009: AAMI Standard for Transcutaneous Electrical Nerve Stimulators" Electrode/Skin Impedance Model (ESIM)
Image /page/8/Figure/4 description: The image shows a graph of SwissStim Voltage in Volts. The graph shows a square wave with a voltage of 20.0U/DIV and a time scale of M 100μs. The image also shows the LeCroy logo and some menu options such as Type, Image, Touche Impr, Enr.Image, and Enregistrer.
Image /page/8/Figure/5 description: The image shows the title of a graph or plot. The title reads "P4 Physio Voltage [V]". The title indicates that the graph or plot displays the voltage of a physiological signal, specifically from location P4, and that the voltage is measured in volts.
| Type | ||
|---|---|---|
| 14. | Image | |
| 15. | Touche.Impr | |
| 16. | Enr.Image | |
| 17. | ||
| 18. | ||
| 19. | ||
| 20. | Enregistrer | |
| 20.00/DIV |
Page 9
9
K112|48 PAGE 10 OF 12
TVDE
Hivox Styline (Voltage [V], load: ESIM) LeCroy REGI promoming my Type louche Imr Enrecistre BUIDI P4 Physio Current [mA] 100 m 200 1 ype
Tited! 200mA/DIU M 100ps
SwissStim Current [mA]
BEEL Rama
Image /page/9/Figure/4 description: The image shows an oscilloscope display with a waveform. The waveform has a sharp positive peak followed by a negative peak, with the rest of the waveform close to zero. The display indicates a vertical scale of 200mA/DIV and a horizontal scale of M 100us.
Comparison of All Devices (Voltage [V], load: ESIM)
~ ��
Image /page/9/Figure/5 description: The image shows a graph from a LeCroy oscilloscope. The graph displays a waveform with a sharp initial peak followed by a rapid decay and then a more gradual decline to a steady-state level. The x-axis is labeled as "M 100us", indicating a time scale of 100 microseconds per division, while the y-axis is labeled as "200mA/DIV", indicating a current scale of 200 milliamperes per division.
HiVox Styline Current [mA]
Image /page/9/Figure/7 description: The image shows an oscilloscope display with two waveforms. The vertical scale is labeled as 200mA/DIV, and the horizontal scale is labeled as M 100us. The title at the bottom reads "Comparison of All Devices Current [mA]".
Image /page/9/Figure/8 description: The image shows the title of a graph or chart. The title is "Comparison of All Devices Current [mA]". The title indicates that the graph or chart will compare the current of all devices, measured in milliamperes (mA).
10
Page 1 1
14. Device Safety
The SWISSSTIM device is as safe and effective, and functions in substantially equivalent manner to the predicate devices cited in Section C9, above.
This device is manufactured in accordance with ISO 9001/2000 and ISO 13485/2003, International Quality Standard, IEC-601-2-10 European Safety Standard and in compliance with all EC medical device directives applicable to Class IIA medical devices.
Valmed, S.A. has never received notification of any adverse safety events related to any Valmed stimulator devices.
The SWISSsma is designed so that even improper or accidental application of the stimulator will not produce cardiac rhythm disturbances (this does not apply to persons who have implanted cardiac pacemakers). This safety factor is due to the minimal electrical charge of the stimulating impulses, which, under all conditions, do not exceed 50 microcoulombs. The effective value of the stimulation voltage a person will experience during treatment with the SWISSsTM is very low, below 7 volts (root mean square) at maximum setting.
A significant safety feature of the SWISSsm (and the P4 Physio) is automatic limitation of stimulation current density on the skin under the electrodes. (i.e., electrical energy delivered per square centimeter) Due to the voltage-source output circuitry, the SWISSSTIM presents minimal risk of skin burns. The skin current densities of Valmed stimulators are, at all times, well below the safe limit of 2 milliamperes (mA) per square centimeter, as required by the IEC 601-2-10 standard. The skin burn hazards caused by many electrostimulators have been widely reported in medical literature and by the FDA. These hazards are minimal in the SWISSsm due to the electronic circuit design incorporated in the output amplifier of the device (a voltage source generator similar to that used in implantable cardiac pacemakers).
Specific safety features include:
- a. It is not possible for users to modify the embedded programs; users can only modify the intensity of stimulation
- b. All programs begin with minimal electrical intensity; the medical professional or patient must increase the intensity to his/her desired treatment level.
- c. Maximum possible electrical impulse charge is 50 microcoulombs.
- d. Automatic control of stimulation current density, thus precluding excessive current density at the electrode-skin interface and ensuring skin safety.
- e. The connector plug precludes the possibility of accidental connection to a power source such as an AC power outlet.
- f. Specific warnings and contraindications in User Manual.
11
All device accessories also meet safety standards; 510(k) cleared electrodes are specified (K872976) and supplied with this device.
Electromagnetic Compatibility and Electrical Safety 15.
FDA recommended testing has been completed, as follows:
| Test | Standards | Result | |
|---|---|---|---|
| Emission | EN 55011 | EN 60601-1-2/EN 60601-2-10 | Pass |
| Immunity to Electrical | |||
| Discharge | EN 61000-4-2 | EN 60601-1-2/EN 60601-2-10 | Pass |
| Immunity to Radiated rf/emf | EN 61000-4-3 | EN 60601-1-2/EN 60601-2-10 | Pass |
| Immunity to Conducted | |||
| Disturbances Induced by rf | |||
| Fields | EN 61000-4-6 | EN 60601-1-2/EN 60601-2-10 | Pass |
| Immunity to Power | |||
| Frequency Magnetic Field | EN 61000-4-8 | EN 60601-1-2/EN 60601-2-10 | Pass |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/12/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of three curved shapes, resembling a stylized caduceus or a representation of the flow of health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Valmed, S.A. % Mr. Carl Magnell Official Correspondent Ave du Tourbillion 34 1950 Sion, Valis Switzerland
APR 3 0 2012
Re: K112148
Trade/Device Name: Powered Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: April 16, 2012 Received: April 19, 2012
Dear Mr. Magnell:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
13
Page 2 - Mr. Carl Magnell
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalToblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
14
A. Indications for Use
510(k) Number: K112148
Device Name: Powered Muscle Stimulator
Indications for EMS use are:
- Prevention or retardation of muscle disuse atrophy A
- Relaxation of muscle spasms
- A Increasing local blood circulation
-
Muscle re-education
-
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or improving range of motion of extremities >
Indications for TENS use are:
- Symptomatic relief and management of chronic, intractable pain, and A
- Adjunctive treatment for post-surgical and post-trauma acute pain A
Prescription Use X (Part 21 CFR 801 Subpart D AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112148