This guidance document replaces documents entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Muscle Stimulators, and Ultrasound Diathermy and Muscle Stimulators," dated July 26, 1995; "Electrical Muscle Stimulator (EMS) Labeling Indications, Contraindications, Warnings, etc.," dated July 11, 1985; and "Technological Reporting for Powered Muscle Stimulator 510(k) Submissions," dated January 1, 1993. The purpose of developing this new document is to provide the sponsor and FDA reviewers/staff with updated and consolidated guidance regarding powered muscle stimulators identified and classified under 21 CFR 890.5850 and reviewed under the premarket notification [510(k)] process. This guidance also serves to correct erroneous and outdated information contained in the previous guidance documents.
e stim files
The sponsor should provide a complete copy of all labels, labeling, as well as all available promotional and advertising materials. Please refer to Attachment I for additional guidance concerning labeling of powered muscle stimulators.
Additional descriptive information specific to powered muscle stimulators should be provided. Please refer to Attachment II for guidance concerning the recommended content and format for reporting technological characteristics of powered muscle stimulators.
The remainder of this labeling guidance lists statements that should be included prominently in the labeling for powered muscle stimulators. These statements address the indications, contraindications, warnings, precautions, and adverse effects associated with the use of powered muscle stimulators:
The sponsor should describe the length(s), construction, materials, and connections between the stimulator device and the electrodes. Sponsor should be aware that electrode lead wires and patient cables intended for use with a medical device are subject to the mandatory performance standard set forth in 21 CFR Part 898. Please refer the Additional Information section at the end of this guidance for further details.
The Firmware files are encrypted data files. Do NOT attempt to edit them as corrupted data files could potentially damage your 2B and will invalidate your Lifetime Guarantee. Click for further instructions on how to install the Firmware.
Plus, more advanced players can even make their own audio files that control the stimulation response exactly as desired. By stringing these files together you can create whole 'stories' that will manipulate your stimulation for your chosen length of time. There's a massive audio-stim community online, with many people sharing their audio files for free, so we also highly recommend checking out www.smartstim.com
Our Flux and AXIS stimulators support stereostim play using a line-in input. This means that when you have a stereo track (that will have Left and Right channels), Flux and AXIS filter these so that the Left audio controls the left output and the Right controls the right output. Controlling the stimulation in this way means that the sensations can be much more dynamic and interesting.
We've created a few extended stereo-stim files that demonstrate just some of the possibilities available with audio play. Don't forget that audio-stim tracks aren't designed to be listened to like music, so it's perfectly normal if they sound strange!
If you're interested in making your own sessions, you can download a selection of library files we've created to help you make your own extended files. By using the free open source audio editing software, Audacity (download here: ) you can paste any of these files together to control your stimulation.
These downloadable files are divided into Synchronised (simultaneously fires channel 1 and 2) and Asynchronous (channel 1 and 2 have different patterns) folders for ease of use, but you can also mix and match these files in Audacity to create new and unusual sensations. Please click the links to automatically download a zip folder of library files which you can use to build your own tracks.
E-stim sends mild electrical pulses through the skin to stimulate muscles or manipulate nerves to exercise muscles, reduce pain, or induce pleasurable feelings. Some e-stim devices accept audio signals to modulate the stimulation allowing for infinite variable patterns of e-stim.
Our E-Stereo e-stim audio server generates patterns that will never repeat, and on top of it the user can adjust the audio from flowing tickling waves to a raging gale. The adjustment possibilities are enormous and a graphical representation of the expected output is displayed.
The server is preloaded with about 10 minutes of data for you to experiment, and then it needs to reload. You will need to register an account and be logged in to enjoy 24/7 continues E-Stereo e-stim audio. Now you are not limited to the playtime of an e-stim audio MP3, we will outlast you!
Drone City! Pulsating stereo e-stim track made using modular synthesis: Plaits, Maths, Magneto, etc. Feels great driving an ErosTek ET312B or E-Stim Systems 2B.
This is a longer, 2-part monophonic e-stim session I composed using a Moog Mother-32 and DFAM while wired up to an ET312B in Audio 2. Feels awesome with an ET232 in Audio Loud too. Enjoy!
You can easily customize Split to send a mono or stereo AudioStim track to one channel while sending the output of another mode to the other. This creates almost limitless possibilities by combining playback of audio with an independent and out-of-sync generation of stim pulses. Great for extended edging and training sessions.
To switch hidden folders on, navigate to Launchpad/Other, run Terminal and in the terminal window type defaults write com.apple.finder AppleShowAllFiles YES This will allow you to see all hidden files and folders.
Few patients recover full hand dexterity after an acquired brain injury such as stroke. Repetitive somatosensory electrical stimulation (SES) is a promising method to promote recovery of hand function. However, studies using SES have largely focused on gross motor function; it remains unclear if it can modulate distal hand functions such as finger individuation.
Eight participants with a history of acquired brain injury and distal upper limb motor impairments received a single two-hour session of SES using transcutaneous electrical nerve stimulation. Pre- and post-intervention assessments consisted of the Action Research Arm Test (ARAT), finger fractionation, pinch force, and the modified Ashworth scale (MAS), along with resting-state EEG monitoring.
Sensory threshold somatosensory electrical stimulation (SES) is a promising therapeutic modality for targeting hand motor recovery [5]. It is known to be a powerful tool to focally modulate sensorimotor cortices in both healthy and chronic stroke participants [5,6,7,8]. Devices such as transcutaneous nerve stimulation (TENS) units can deliver SES and are commercially available, inexpensive, low risk, and easily applied in the home setting [9]. Previous studies have demonstrated short-term and long-term improvements in hand function after SES [5, 10,11,12,13,14,15]. However, the effect of SES on regaining the ability to selectively move a given digit independently from other digits (i.e. finger fractionation) has not been investigated. Poor finger individualization is an important therapeutic target because it is commonly present even after substantial recovery and may account for chronic hand dysfunction [16]. Further, it is unclear if SES is associated with compensatory or restorative mechanisms. Prior studies have largely relied on relatively subjective clinical evaluations of impairment, such as the Fugl-Meyer Assessment, or timed and task-based assessments, such as the Jebson-Taylor Hand Function Test. Biomechanical analyses, on the other hand, can provide important objective and quantitative evidence of improvement in neurologic function and normative motor control [17, 18]. Therefore, we aimed to determine not only the functional effects, but also the kinematic effects, of SES on chronic hand dysfunction.
a Schematic representation of the method used for calculating the FCI. The participant is instructed to flex only the index finger as much as possible without flexing the other digits. b FCI is defined mathematically as the angle traversed by the middle finger (digit A) divided by the angle tranversed by the index finger (digit B) relative to the horizontal starting position. c Statistically significant change in mean fractionation from baseline to immediately after peripheral nerve stimulation. Fractionation improvement is indicated by a decrease in finger coupling index (FCI)
TENS was performed using a commercially available device (ProStim, Alimed Inc., Dedham, Massachusetts, USA). One pair of 2 3.5 in. rectangular electrodes (Vermed ChroniCare TENS Electrodes, Vermed, Buffalo, NY, USA) were placed on one aspect of the forearm to simultaneously stimulate both median and ulnar nerves, while a second pair of round 2 in. diameter electrodes were placed on the lateral aspect of the forearm to stimulate the radial nerve. (Additional file 1: Figure S2) Optimal positions to stimulate the ulnar, median and radial nerves of the paretic hand were determined by using standard localization technique [26, 25]. Sensory thresholds (minimum intensity of stimulation) at which subjects report paresthesias in each nerve territory were determined. Stimulus intensity was further increased and adjusted until subjects reported strong paresthesias in the absence of pain and visible muscle contractions. The mean stimulation intensity was 5.3 mA (19% above mean sensory threshold) for the radial nerve and 5.8 mA (29% above mean sensory threshold) for the median/ulnar nerves. Bursts of electrical stimulation at 10 Hz (100 microsecond pulse width duration) were delivered to all nerves simultaneously for 2 h [5, 10, 12,13,14,15, 18]. During the stimulation period, the affected hand was at rest while participants read or viewed a film. 2ff7e9595c
Comments