How our electrotherapy device works?
Using bioelectricity technology, the device sends low frequency bioelectrical pulses to your muscles through the conductive electrode pads.
Your muscles respond to the impulses by contracting and relaxing rhythmically. The contracting and relaxing of your muscles produces soothing massage sensations that are similar to that given by a massage specialist.
The sensation of massage is very real. You’ll wonder who is administering your massage–but it’s just the device! It penetrates muscle group deeper than human hands can.
When you place electrode pads in the pain points, you will feel instant relaxation and pain relief. Using modern human body simulation technology to simulate ancient Chinese therapeutic methods and digital programming technology, your control unit has 6 different massage modes: Tuina, Acupuncture, Tapping, Guasha , Bodybuilding and auto mode. It has adjustable 20 intensity Levels, adjustable 10-60 time settings, battery charging indicator and safe lock.
How HealthmateForever electrotherapy device works for pain relief?
HealthmateForever medical devices use TENS technology, TENS stands for Transcutaneous (through the skin) Electrical Nerve Stimulation and is a treatment that uses low voltage electrical currents to relieve pain and provides othertherapeutic benefits.
A gentle electrical current is passed through electrodes which are attached to the skin near the site of the pain or discomfort. The pulses send bio-electrical signals through the central nervous system, thus blocking pain receptors. Exactly the same way as a strong painkiller would work.
EMS works to mimic the body’s natural muscle movements; signals are sent between the gel pads (on the garment), switching on the nerves that control your muscles and causing them to contract naturally. EMS technology has been used for over 40 years in hospitals, clinics and physiotherapy practices around the world to strengthen and rehabilitate muscles.
HealthmateForever combined TENS & PMS units are nerve stimulators for pain relief and muscle stimulators for muscle conditioning that use self-adhesive electrode pads to target specific nerve and muscle areas. Our electrode pads do not require gel or creams to be applied to the skin and can be used up to 100 times with proper maintenance. We offer a wide variety of high quality replacement electrode pads in varying sizes, shapes, and colors to allow for effective pain treatment and muscle conditioning.
FDA cleared Class II OTC HealthmateForever TENS & PMS devices combine modern digital prorgramming technology, TENS & EMS technology, bioelectricity technology and human body simulation technolog with ancient Chinese therapeutic methods. Unlike the electrotherapy devices used by many doctors, physical therapists, and other healthcare professionals our personal electrotherapy devices such as TENS & PMS units are compact, portable, and easy to use. You can fit your HealthmateForever in a purse or a pocket which allows our clients to go anywhere, at anytime and treat their pain and recondition their muscles.
Many of our clients have tried Western medicine to attempt to alleviate their pain. Some tried surgery, pills, steroid shots etc, but with no better results. Once our clients tried HealthmateForever, they found solutions to their pain relief and muscle reconditioning and finally are experiencing long lasting relief for a fraction of the cost.
As a product developer, designer and manufacturer, Healthmate is a customer-oriented provider of great quality products at great prices! We’re focused on customer satisfaction and have built our reputation based on great friendly service and honesty.
Since HealthmateForever products were launched to the market in 2010, HealthmateForever gained high reputation. Over a million of people worldwide benefit from HealthmateForever products. Healthmate will continue to improve our products to reward our loyal customers.
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 without prescription.
FDA premarket approval
By constantly being more competitive in features, functions, prices and aftersale services Healthmate International brings our consumers state of the art TENS and PMS medical devices.
- Establishment Registration and Device Listing with FDA in class I or Class II
- HealthmateForever TENS devices complies 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
- TENS & PMS devices are in accordance with International Standard ISO 14971- Medical devices –Application of Risk Management to Medical Device
- TENS & PMS devices are in accordance with International Medical Standard ISO13485
Production Line :
All 510k documents must be sufficient and meet FDA regulations as policy is updated from time to time. If the products do not meet FDA requirements and get FDA premarket approval, FDA will issue warnings, recall or penalize as FDA considers any medical devices without FDA premarket approval is illegal.
FDA Clearance Process
The FDA approves drugs and generally Clears medical devices for Marketing. 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 are the devices that have 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.
Import and export service
Custom and FDA clearance
We specialized in international business practices, import and export regulations and compliance, avoid import refusal due to regulatory negligence, apply right tariff code, avoid unnecessary loss or penalty due to import refusal by FDA and customs.
All the medical devices must meet custom and FDA compliance. First, FDA sent us FDA Hold Request. After inspection of medical devices and verification of our FDA documents, they will release, but FAILURE TO COMPLY CAN / MAY RESULT IN PENALTIES AND/OR SEIZURE OF FREIGHT.
Here are examples of FDA HOLD REQUEST and FDA RELEASE.
Subject: 07-07-4054959 FDA Hold Request
Once this shipment arrives at the warehouse, you may stage it in a secure area. However, FREIGHT MUST REMAIN INTACT IN A DESIGNATED AREA UNTIL FDA HAS RELEASED. FAILURE TO COMPLY CAN / MAY RESULT IN PENALTIES AND/OR SEIZURE OF FREIGHT.
Subject: 07-07-4054959 FDA Release
Shipment is fully released from FDA.Please make sure to advise your warehouse.
Note: once your merchandise is seized by custom or FDA due to failure to comply with FDA compliance and regulation, you may result in import refusal or penalty etc.