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HealthmateForever® medical devices are FDA cleared Class II, OTC for safety and effectiveness, no prescription needed.

Posted by Healthmate Forever on

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.

 

Legal Department

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

 


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