Case Study

Success story for FDA 510(k) Assistance and for business development Health related.

A. Health Related Business Development success story

Our team at UpSynergy has vast experience with Business Development for Health Care related products. We have been launching new and innovative products for manufacturers of health-related products for more than 30 years in the US market and in more than 35 countries worldwide. We have successfully built the business and sales for dozens of health product manufacturers. One of the medical companies we launched the sales and marketing for is called MedX Health Corp. a medical manufacturer ( We launched their sales in the US and Europe for a Laser therapy product line and a skin cancer screening product line. Now we have their products selling in almost 40 countries worldwide.

Another company with a health care product that we did work for is called Theradome, Inc. a manufacturer of the product called LaserCap which is used for hair growth. The website is We did their FDA application and approval process and successfully obtained the FDA approval for their products. We consulted to this company and helped them develop a good product launch strategy which we then implemented. The sales have grown steadily at a very fast rate

B. FDA registration success story

At UpSynergy we have professional regulatory experts that have been assisting medical product manufacturers and makers of health-related consumer products to get their products approved by the US FDA so the products can be sold inside the US. We have 25 years of experience helping companies get their products FDA approved. We can assist your company with products ranging from health foods, cosmetics, supplements, vitamins, medical devices and pharmaceuticals. We have obtained FDA approvals for more than 65 Companies.

In addition to assisting with FDA work in the US, we also have strong experience with registering health related products in many other countries around the world. If you want to expand your sales to many other countries we can not only get your product approved and registered in those countries, but we will also set up your sales and distribution network in each country.

One example of the assistance we provide to our client companies is complete FDA all-inclusive package for FDA product registration, Listing and Approval. We include everything from the start until the end when your product receives FDA approval.

One company we served for this FDA package is named REKA HEALTH Corp.

We started by gathering all the technical data, product information and specifications, and test reports for the company’s products. Then we began drafting a long list of documents that FDA requires. The preparation of all required documents, forms , test report, etc. takes about 2 months to complete by our staff. Then we review the final draft of the entire submission package for a 510(k) application. Typically the documents together total more than 500 pages. Once approved by your company’s management staff, we file the package with the FDA. Then we follow up with the FDA staff of experts and professionals to make sure that all of their questions are answered properly. During the time while FDA is reviewing this submission they usually have many questions. We take care of this for you. Finally after approximately 3 months, the FDA will issue a 510(k) approval letter to your company. From that day on you can sell your products into the large US market for Health Related products.