FDA CLEARED CLASS II OTC Products
FDA cleared Class II OTC (Over the Counter) HealthmateForever TENS & PMS devices combine modern digital prorgramming technology, TENS & EMS technology, bioelectricity technology and human body simulation technology with ancient Chinese therapeutic methods. Usually the electrotherapy devices used in the clinic by many doctors, physical therapists, and other healthcare professionals, they are bulk in size, also need prescriptions, but our personal home electrotherapy devices such as combined 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 relieve their pain and condition their muscles. Enjoy unlimited soothing therapy in the comfort of home, without worrying about scheduling medical appointment, ask sick day leave, gas and expensive health bills for multi sessions of physical therapy (normally around $75 per hour in the chiropractor's office, even if you have insurance, you still need to copay).
Many of our clients have tried Western medicine to attempt to alleviate their pain. Thousands of testimonials and feedback are very supportive to our medical devices such as TENS and muscle stimulators. Some tried surgery, pills, steroid shots etc, but with no better results. Once our clients tried HealthmateForever TENS and muscle stimulators, they found solutions to their pain relief and muscle conditioning and finally are experiencing long lasting relief for a fraction of the cost.
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, Healthmate Forever gained high reputation. Over a million of people worldwide benefit from HealthmateForever therapy products. Healthmate will continue to improve our products to reward our loyal customers.
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.
Conformity to safety and performance standards:
- 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
HealthmateForever® medical devices are FDA cleared Class II, OTC for safety and effectiveness, no prescription needed.
Healthmate's intellectual property: copyrights, Patent, Pending Patent and trademark reserved by Healthmate International, LLC
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
HealthmateForever medical device TENS and muscle stimulators are in accordance with International Standard ISO 14971- Medical devices –Application of Risk Management to Medical Devices.
Lifetime warranty, 100% guarantee free from manufacturer’s defect for the HealthmateForever TENS and muscle stimulators.
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.