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

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 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.

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 SWISSSTIM 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 meta-analyses have confirmed TENS effectiveness for postoperative pain, osteoarthritis, and chronic musculoskeletal pain.

AI/ML Overview

The provided text describes the SWISSSTIM device, a battery-powered transcutaneous nerve and neuromuscular electro-stimulation device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance validation studies with human subjects. Therefore, much of the requested information regarding sample sizes, expert ground truth, adjudication methods, and MRMC studies is not typically found in such a submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria & Reported Device Performance:

The document outlines performance characteristics of the SWISSSTIM and compares them to predicate devices (P4-PHYSIO and Styline 882). The acceptance criteria are implicit in showing similar technical characteristics and safety profiles to the legally marketed predicate devices.

Parameter	Acceptance Criteria (based on predicate equivalence)	SWISSSTIM Performance (K112148)
Indications for Use (EMS)	Equivalent to predicate devices (P4-PHYSIO, Styline 882): 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, Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or improving range of motion of extremities. (Note: "muscle re-education" in SWISSSTIM vs. "muscle re-education and strengthening" in predicates - considered equivalent)
Indications for Use (TENS)	Equivalent to predicate device (Styline 882 for TENS): Symptomatic relief and management of chronic, intractable pain, and Adjunctive treatment for post-surgical and post-trauma acute pain.	TENS: Symptomatic relief and management of chronic, intractable pain, and Adjunctive treatment for post-surgical and post-trauma acute pain.
Safety - Manufacturing Quality Standards	Complies with ISO 9001/2000, ISO 13485/2003, IEC-601-2-10 European Safety Standard, and EC medical device directives for Class IIA.	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.
Safety - Auto Current Limit	Automatic limitation of stimulation current density (similar to P4 Physio).	Automatic limitation of stimulation current density at the electrode-skin interface, ensuring skin safety. (Also a feature of the P4 Physio, unlike Styline 882).
Safety - Program Modification	Embedded programs cannot be changed; users can only modify intensity (similar to P4 Physio).	Embedded programs cannot be changed; users can only modify the intensity of stimulation.
Safety - Initial Intensity	All programs begin with minimal electrical intensity.	All programs begin with minimal electrical intensity; the medical professional or patient must increase to desired treatment level.
Safety - Max Electrical Impulse Charge	Max electrical impulse charge around 23-50 µC (P4 Physio is 23 µC, Styline 882 not provided). Implicitly, not exceeding 50 µC for cardiac safety.	Maximum electrical impulse charge is 50 micro-coulombs. This is stated to ensure it will not produce cardiac rhythm disturbances (except for pacemakers).
Safety - Connector Plug	Lead cables preclude accidental connection to a power source (similar to both predicates).	Lead cables preclude the possibility of accidental connection to a power source such as an AC power outlet.
Safety - Warnings/Contraindications	Specific warnings and contraindications in User Manual.	Specific warnings and contraindications in User Manual.
Safety - Skin Current Density	Skin current densities well below 2 mA/cm² as per IEC 601-2-10 (similar to P4 Physio).	Skin current densities 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.
Technical - Peak Voltage (500Ω load)	50V (peak value) ± 10% (implied by predicate comparison). The provided images show similar voltage waveforms for all devices.	Delivers stimulation pulses of 50v (peak value) ± 10% onto 500Ω at maximum settings. (Waveform images are provided but numerical values are only explicitly stated for SWISSSTIM).
Technical - Peak Current (500Ω load)	100 mA (peak value) (implied by predicate comparison). The provided images show similar current waveforms for all devices.	Corresponds to 100 mA (peak value) current intensity (on 500Ω load). (Waveform images are provided but numerical values are only explicitly stated for SWISSSTIM).
Technical - Impulse Frequencies	1 Hz to 120 Hz (implied by predicate comparison).	In a range of 1 Hz to 120 Hz, depending on the choice of stimulation program.
Technical - Voltage Waveform	Rectangular monophasic.	Rectangular monophasic impulses.
Technical - Impulse Duration	20 µs to 1000 µs.	From 20 us to 1000 us.
Technical - Current Waveform (500Ω load)	Monophasic.	Monophasic on 500 Ω load.
EMC/Electrical Safety Testing	Pass all relevant standards: EN 55011, EN 61000-4-2, EN 61000-4-3, EN 61000-4-6, EN 61000-4-8.	Passed all listed tests (Emission: EN 55011; Immunity to Electrical Discharge: EN 61000-4-2; Immunity to Radiated rf/emf: EN 61000-4-3; Immunity to Conducted Disturbances Induced by rf Fields: EN 61000-4-6; Immunity to Power Frequency Magnetic Field: EN 61000-4-8).

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is primarily a non-clinical performance and substantial equivalence comparison study against two predicate devices: P4-PHYSIO (K022175) and Styline 882 (K092448).

Non-Clinical Performance Data: The document states, "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)". This involved electrical performance testing, likely using bench testing methods and an ESIM to simulate skin impedance.
Substantial Equivalence Argument: The core of the submission relies on demonstrating that the SWISSSTIM has similar technological characteristics (design, materials, energy source, waveforms, programs), indications for use, safety features, and operational parameters as the legally marketed predicate devices. Visual comparisons of voltage and current waveforms across different load resistances (500 ohms, 2000 ohms, 10000 ohms, and ESIM) are provided to support this. The detailed comparison table further highlights similar safety and efficacy aspects.
Compliance with Standards: The device's manufacturing quality (ISO 9001/2000, ISO 13485/2003) and electrical safety (IEC-601-2-10 European Safety Standard and all EC medical device directives) were tested and reported to be compliant. Electromagnetic Compatibility (EMC) and Electrical Safety tests were conducted according to FDA recommended testing with "Pass" results for all listed standards (EN 55011, EN 61000-4-2, EN 61000-4-3, EN 61000-4-6, EN 61000-4-8).

Details not explicitly stated in the document:

Sample size used for the test set and the data provenance: This is a 510(k) submission primarily relying on non-clinical bench testing and comparison to predicates. There isn't a "test set" in the context of clinical data or human subjects. The graphical data (waveforms) would represent measurements from the physical devices under various load conditions. The data provenance would be the test labs where these electrical measurements were performed, likely in Switzerland (Valmed's location). This is not specified as retrospective or prospective in a clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for electrical performance is established by measurement instruments calibrated to standards.
Adjudication method for the test set: Not applicable for non-clinical bench testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is typically for diagnostic imaging devices involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a physical electro-stimulator, not an algorithm. Its standalone performance is demonstrated through the electrical and safety tests.
The type of ground truth used: For the non-clinical performance evaluation, the "ground truth" is derived from physical measurements against established electrical engineering standards and the specified performance of the predicate devices. For safety and efficacy, the ground truth is based on compliance with international standards (ISO, IEC, EC MDD) and a demonstration of substantial equivalence to already cleared devices with known safety and efficacy profiles.
The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

APR 3 0 2012

'age

<112148

A. 510(k) Summary as Required by Section 807.92(c)

1. Owner

Valmed, S.A.

2. Address

Avenue du Tourbillon 34, Sion 1950, Valais, Switzerland

3. Phone

+41 27 203 65 81

4. Fax

+41 27 203 65 87

5. Website

www.valmed.ch

6. Contact Persons

Switzerland: Vincent Tellenbach - Vincent.tellenbach@valmed.ch United States: Carl Magnell comagnell@gmail.com

7. Date Prepared/Finalized

22 July 2011/Finalized 23 April 2012

8. Name of Device

SWISSSTIM Trade Name: Battery-powered device for transcutaneous nerve and Common Name: neuromuscular electro-stimulation

Classification Name: Panel/Product Code/Regulation: 89 IPF CFR 890.5850 and subsequent Panel/Product Code/Regulation: 88 GZJ, 882.5890

9. Predicate Devices

This device is substantially equivalent to the following legally marketed devices:

P4-PHYSIO (K022175), and Styline 882 (K092448)

{1}------------------------------------------------

Page 2

10. Indications for Use

The Indications for Use for the SWISSSTIM are shown below:

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

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.

{2}------------------------------------------------

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]


		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
Indicationsfor Use	EMS:> Prevention orretardation ofmuscle disuseatrophy> Relaxation ofmuscle spasms> Increasing localblood circulation> Muscle re-education> Immediate post-surgical stimulationof calf muscles toprevent venousthrombosis> Maintaining orimproving range ofmotion ofextremities	EMS:> Prevention orretardation ofmuscle disuseatrophy> Relaxation ofmuscle spasms> Increasing localblood circulation> Muscle re-education andstrengthening> Immediate post-surgical stimulationof calf muscles toprevent venousthrombosis> Maintaining orimproving range ofmotion ofextremities	EMS:> Prevention orretardation ofmuscle disuseatrophy> Relaxation ofmuscle spasms> Increasing localblood circulation> Muscle re-education andstrengthening> Immediate post-surgical stimulationof calf muscles toprevent venousthrombosis> Maintaining orimproving range ofmotion ofextremities
	TENS:> Symptomatic reliefand managementof chronic,intractable pain,and> Adjunctivetreatment for post-surgical and post-	TENS:> Symptomatic reliefand managementof chronic,intractable pain,and> Adjunctivetreatment for post-
	trauma acute pain
Safety	1- Complies withISO 9001/2000 andISO 13485/2003,International QualityStandard, IEC-601-2-10 EuropeanSafety Standardand in compliancewith all EC medicaldevice directivesapplicable to ClassIIA medical devices.2 - Automaticlimitation ofstimulation currentdensity3 - Embeddedprograms cannot bechanged; users canonly modify theintensity ofstimulation4 - All programsbegin with minimalelectrical intensity;the medicalprofessional orpatient mustincrease theintensity to desiredtreatment level5 - Maximumelectrical impulsecharge is 50 micro-coulombs6 - Automaticstimulation currentdensity controlprecludes excessivecurrent density atthe electrode-skininterface, ensuringskin safety7- Lead cablespreclude thepossibility ofaccidentalconnection to apower source such	1- Complies withISO 9001/2000 andISO 13485/2003,International QualityStandard, IEC-601-2-10 EuropeanSafety Standardand in compliancewith all EC medicaldevice directivesapplicable to ClassIIA medical devices.2 - No automaticlimitation ofstimulation currentdensity3 - Users candesign individualprograms as well asmodify the intensityof stimulation4 - All programsbegin with minimalelectrical intensity;the medicalprofessional orpatient mustincrease theintensity to desiredtreatment level5 - Maximumelectrical impulsecharge is notprovided6 - No automaticstimulation currentdensity control7- Lead cablespreclude thepossibility ofaccidentalconnection to apower source suchas an AC poweroutlet8 - Specificwarnings andcontraindications inUser Manual	1- Complies withISO 9001/2000 andISO 13485/2003,International QualityStandard, IEC-601-2-10 EuropeanSafety Standardand in compliancewith all EC medicaldevice directivesapplicable to ClassIIA medical devices.2 - Automaticlimitation ofstimulation currentdensity3 - Embeddedprograms can notbe changed; userscan only modify theintensity ofstimulation4 - All programsbegin with minimalelectrical intensity:the medicalprofessional orpatient mustincrease theintensity to desiredtreatment level5 - Maximumelectrical impulsecharge is 23 micro-coulombs6 - Automaticstimulation currentdensity controlprecludes excessivecurrent density atthe electrode-skininterface, ensuringskin safety7- Lead cablespreclude thepossibility ofaccidentalconnection to apower source such

Page 7

{7}------------------------------------------------

K112148

PAGE 8 OF 12

း

వ

网

Page 8

{8}------------------------------------------------

KI1214 PAGE 9 OF 12

Efficacy	The EMS programsare substantiallyequivalent to theEMS programs inthe P4 Physio.The 10 TENSprograms aredesigned to parallelthe TENS programsin the predicatedevice. There arevariations but theserelate to stimulationpatterns rather thanfrequency ranges.	There are 10 EMSand 10 TENSprograms	FDA cleared with 4EMS programs thathave six (6)Indications for Use,including:• Relaxation ofmuscle spasms• Prevention orretardation ofdisuse atrophy• Increasing localblood circulation• Muscle re-education• Immediate post-surgical stimulationof calf muscles toprevent venousthrombosis, and• Maintaining orincreasing range ofmotion
Operation	Ease of Use: Onlyselection ofprograms, phasesand intensity levelsare possible;intensity levels areset independentlyfor each channel.Pre-treatmentpreparation andpost-treatmentinstructions are thesame as those forboth predicatedevices.	Ease of Use: User'shave additionaloptions and canselect not onlyprograms andintensity levels butalso programduration time andpulse rates (HZ).These featuresmake this predicatedevice morecomplex to operate.	Ease of Use: Onlyselection ofprograms, phasesand intensity levelsare 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 ElectricalDischarge	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 ConductedDisturbances Induced by rfFields	EN 61000-4-6	EN 60601-1-2/EN 60601-2-10	Pass
Immunity to PowerFrequency Magnetic Field	EN 61000-4-8	EN 60601-1-2/EN 60601-2-10	Pass

{12}------------------------------------------------

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

Regulation Number and Section

§ 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).