TENS - TRANSCUTANEOUS ELECTRICAL NERVE STIMULATIONS
Transcutaneous Electrical Nerve Stimulations (TENS) are safe non-invasive, drug-free methods of pain management. TENS is currently one of the most commonly used forms of electro- analgesia.The TENS device relieves pain by sending small electrical impulses through electrodes placed on the skin to underlying nerve fibers. TENS works by two different mechanisms:
- First, electrical stimulation of the nerve fibers can block a pain signal from being carried to the brain. If the signal is blocked, pain is not perceived.
- Secondly, the body has its own mechanism for suppressing pain. It does this by releasing natural compounds called endorphins which act as analgesics.
By effectively managing pain without drugs, TENS allows many people with chronic pain conditions, to resume normal daily activity. TENS has proven to be beneficial in the treatment of acute and chronic pain caused by pain related medical conditions. When TENS is used as an analgesic, patients are instructed to try different frequencies and intensities to find those that provide them with the best pain control. Optimal settings of stimulus parameters are subjective and are determined by trial and error. Electrode positioning is quite important. Electrodes are initially placed on the skin over the painful area, but other locations may give comparable or even better pain relief such as:
- over cutaneous nerves
- trigger points
- acupuncture sites
Patient comfort is a very important determinant of compliance and consequently the overall success of treatment. The intensity of the impulse is a function of pulse duration and amplitude. Greater pulse widths tend to be more painful.The amount of output current depends on the combined impedance of the electrodes, skin, and tissues.
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Neuromuscular electrical stimulation (NMES) is the application of electrical stimuli to a group of muscles, most often for the purpose of muscle rehabilitation. This technique is primarily used by physical therapists as a form of rehabilitation after injury, stroke, or other incident that results in the loss of muscle functions. NMES is achieved by passing an electrical impulse from a device through electrodes placed on the skin over the targeted muscle or muscles.
For the purpose of rehabilitation, neuromuscular electrical stimulation is typically used in conjunction with other methods of physical therapy. The intent of is to stimulate the nerves in the muscle with electrical impulses, since they are a natural part of the normal communication between the brain and the muscular system in an uninjured or unaffected body. With this therapy, these natural impulses are simulated and can help “retrain” the muscles to function again.
Even with the use of NMES, most rehabilitation patients must also undergo physical therapy to prevent muscles from atrophying, or dying. In some cases, depending on the cause and extent of injury, other forms of electrical stimulation therapy may also be used. Similarly, the same electrical technology is used to measure the performance of nerves and muscles for diagnostic purposes and measuring improvement.
- damage to bones
- joints, muscles
- ligaments and tendons
How does it work?
Neurostimulation provides pain relief by blocking the pain messages before they reach the brain. The neurostimulator sends out mild electrical impulses that reach the brain faster than the pain signal can arrive. In other words, it outsmarts your pain. Instead of pain, you feel a tingling sensation.
A neurostimulator is a surgically implanted device about the size of a small stopwatch. It delivers mild electrical signals to the epidural area near your spine through one or more thin wires, called leads. The electrical signals cause a tingling sensation in the area of your chronic pain.
You can adjust the strength and location of stimulation using a handheld programmer. For example, you can regulate different levels of stimulation at different times of the day or for various activities – such as walking, sleeping, or sitting. When using a neurostimulator, can automatically adjust stimulation when you are upright (sitting or standing), lying down, or active while in an upright position.
A COMPLETE NEUROSTIMULATION SYSTEM INCLUDES SEVERAL COMPONENTS:
- Neurostimulator – The device that generates the electrical impulses (usually placed under the skin in your abdomen or upper buttock)
- Leads – Thin, insulated medical wires that deliver electrical pulses to the epidural space near the spine
- Physician’s programmer – A computer at your doctor’s office that lets your doctor adjust the neurostimulation system and its settings
- Patient’s programmer – A handheld device you can use at home to customize the stimulation (within the settings your doctor has selected)
The neurostimulation system does not make any noise. It may be felt as a small bump under your skin, but does not normally show through your clothes.
NEUROSTIMULATION PROVIDES ADVANTAGES OVER OTHER THERAPIES FOR CHRONIC PAIN:
- Unlike other chronic pain treatments or surgeries, you can experience neurostimulation and see if it relieves your pain before committing to the long-term therapy.
- A screening test serves as a temporary evaluation period. The screening test is much like an injection, but instead of medication being placed into the epidural space, leads are positioned and connected to an external neurostimulator (battery pack)
- It does not have to be a permanent procedure. The neurostimulator can be surgically removed if you do not like it or if you decide to pursue a different treatment
- Unlike oral medications that circulate throughout your entire body, neurostimulation targets the precise area where you are feeling pain
- A neurostimulator may provide relief when other treatments – like medications or injections – have not
Neurostimulation may reduce your chronic pain and improve your ability to go about your daily activities. Talk to your doctor about the benefits and risks associated with using a neurostimulator for your chronic back and leg pain.
HealthmateForever® medical devices are FDA cleared Class II, OTC for safety and effectiveness, no prescription needed.
Be aware! Don’t be fooled by some competitors.
It is illegal to sell TENS & PMS/EMS medical devices without FDA cleared Class II, OTC in the general public. If you find competitors sell TENS & PMS massagers Class I, please report to FDA as TENS and PMS powered muscle stimulators must be FDA cleared Class II for safety and effectiveness.
If some company tells lie to cheat customers without business moral, please file complaint with Attorney General for consumer protection.
For safety and effectiveness, customers have right to request for medical certificate of the medical devices Class II, OTC issued by FDA. If the company can not provide FDA 510K number or FDA clearance letter, please report to FDA as it is illegal to sell TENS & PMS massager without FDA clearance Class II, OTC (Over the Counter) on the market! Please check our FDA 510K class II, OTC Clearance Letter issued by FDA, stating Brand name.
Conformity to safety and performance standards
All the TENS & EMS/PMS devices for sale at this website comply with the following standards and FDA guidance of TENS and Powered Muscle Stimulator. IEC60601-1, IEC60601-1-2, IEC60601-2-10, ISO10993-5, ISO10993-10
Also in accordance with International Standard ISO 14971- Medical devices –Application of Risk Management to Medical Devices.
Please check the medical certificates below:
The FDA approves drugs and generally Clears medical devices as premarket approval (PMA). Both the approval and the clearance documents submitted undergo intense scrutiny and multiple reviews.
The purpose of a 510(k) submission to the FDA is to demonstrate that a device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976). The submission compares and contrasts the subject and predicate devices, explaining why any differences between them should be acceptable.
While human data is not required for all 510(k), in many cases efficacy data from well-controlled clinical studies proving efficacy and safety are required especially for new indications. This is especially true for a new indication such as “promotion of body health” with TENS and powered muscle stimulators.. The HealthmateForever TENS and powered muscle stimulators. was subject to this more stringent requirement in that the results of large clinical studies complying with all Good Clinical Practices and Safety & Performance Tests had to be submitted with each 510(k) submission for rigorous review.
When a company receives this Clearance, there are stringent rules and high standards put into place covering all aspects of manufacturing and quality control. The HealthmateForever TENS and powered muscle stimulators.is the device that has been reviewed by the FDA and Cleared for marketing. It is these Clearances for marketing that allow us to ensure the effectiveness and safety of the HealthmateForever TENS and powered muscle stimulators.
- TENS: Transcutaneous Electronic Nerve Stimulators
- EMS: Electronic Muscle Stimulator. Now called PMS: Powered Muscle Stimulator.
- FDA class II: ensures safety and effectiveness of medical devices.
- OTC: Over the counter use. FDA allows OTC medical devices to sell to the general public.
- Production Line and Final QC Test