Global Distribution Opportunity
HealthmateForever innovative portable full body TENS & PMS massagers are sold in a professional presentation at trade show, kiosk, storefront, online store, clinic, wellness center and sports club. We offer wholesale and drop shipping services to dealers, chiropractors, physical therapists, physicians, physical trainers and individuals. We always guarantee the best quality, best price and best service for our products as our manufacturer was inspected by the third party authorized by FDA for quality and safety and our products are FDA cleared Class II, OTC, no prescription needed. If you are interested in selling our products, please contact us for more details of how to become a dealer.
The World Health Organization (WHO) published an official report listing of symptoms, conditions and diseases that have been shown in controlled trials to be treated effectively by Acupuncture. Click here to view entire document [WHO: Diseases and disorders that can be treated with acupuncture]
Remedy? Chemistry? The Better Choice is HealthmateForever The special value of the devices is that it frees you of daily use of many drugs and medications.
You can benefit from:
We are proud, we are the first company to have patent design of the iPod size tens ems unit with backlit in August, 2012;
We are the first one to have patent design of independent intensity control in both AB channels in the iPod size TENS EMS units;
We are the first one to have patent design of both mode and intensity selection in AB channels in January, in 2014;
We are the first one to have patent design of Touch Screen TENS EMS units in 2014.
We are proud to be in a leading place in the innovative pocket size TENS EMS unit line. All the copyrights and patent are reserved by Healthmate International, LLC. We take legal action against any knock off similar items. For a large order of TENS EMS units, we are willing to offer opportunity of the private label per licensed agreement
Due to high demand, now we only accept application from pharmacy stores, clinics, hospital gift shops, health club, fitness or wellness center.
Thank you for your interest in becoming a dealer of our products. Please email us for application form. We will send you application form and evaluate qualification. Once you become a distributor, you will get distribution packet.
Healthmate International, LLC
8901 Washington Street
Kansas City MO 64114
Toll free: 1-888-860-7788
It is illegally to sell TENS and EMS or PMS medical devices without FDA cleared Class II, OTC in the general public. If you find competitors sell TENS EMS unit FDA registered Class I, please report to FDA as TENS and PMS powered muscle stimulators must be FDA cleared Class II for safety and effectiveness. They may get warning and penalized by FDA.
Design and development of innovative healthcare products available. FDA 510K consulting service available Specialized in TENS and PMS devices. Preparation of FDA 510K is time consuming and costly. All the tests must be carried out in the authorized labs in accordance with ISO, IEC or EN standards. All 510k documents must be sufficient and meet FDA regulations as policy is updated from time to time. If your products do not meet FDA requirements, you may suffer great loss or may be given FDA warnings or penalized. Import and export service available 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. We have bilingual specialist in US-China trade with emphasis on pharmaceutical products and services. WE have offices in both US and China. We can serve US companies doing business in China: 1. Being your business agent and representative in China, help you buy raw materials and sell your finished products in China. We can serve Chinese companies doing business in the US: 1. Being your business partner and representative in the US. 2. Help you sell your products in US and buy … Custom and FDA clearance 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 cases 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. Shipping Service We have a long term business relationship with our shipping company who can provide excellent service and reasonable rate, fast safe shipment including Inland, Ocean Shipping, Inland (Train and truck) transportation from China to many countries such as USA, Canada, Australia etc . Production Line and Final Quality Test
Conformity to safety and performance standards
This device 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
Also in accordance with International Standard ISO 14971- Medical devices –Application of Risk Management to Medical Devices.
Please check our FDA 510K class II, OTC Clearance Letter issued by FDA
FDA Clearance Process
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 with premarket approval (510K medical certificate).