• Customer Service
  • 1.888.416.4441

  • Weekdays - 9AM-5PM

Welcome to our new Online Resource Center




Certifications and Registrations

Some of the certifications, approvals, and registrations our products have received are shown in the following information.

HEATING PADS

Therasage retained the services of Underwriters Laboratories (“UL”), an independent, not-for-profit product safety testing and certification organization, to review, and evaluate whether our Heating Pad complies with Federal laws and regulations associated with safety and effectiveness. Upon that review, the U.S. Food and Drug Administration, specifically its Division of Surgical, Orthopedic and Restorative Devices’ Office of Device Evaluation, acknowledged this product for marketing in the United States.   Consequently, this device is marketed and advertised in full compliance with the Medical Device amendments to the Federal Food and Drug Act.

A patent is currently pending with the United States Patent and Trademark Office for this device.

The additional standards that we have met regarding this device include: 

1. Registration with the United States Customs and Border Protection, U.S. Department of Commerce, and the US Food and Drug Administration, as required under Section 201(h), Federal Food, Drug, and Cosmetic Act (Registration numbers available upon request.)
2. Compliance with the regulations of the Federal Trade Commission, as required under 15 U.S.C. §1451 (Fair Packaging and Labeling Act)
3. Compliance with ISO 10993-18 (addressing biocompatibility), as determined by four separate and independent tests performed by the North American Science Associates, Inc. (“NAMSA”)

HEATING BELT

Similarly,  this device is marketed and advertised in full compliance with the Medical Device amendments to the Federal Food and Drug Act. A patent is currently pending with the United States Patent and Trademark Office for this device.

The additional standards that we have met regarding this device include:

1. Registration with the United States Customs and Border Protection, U.S. Department of Commerce, and the US Food and Drug Administration, as required under Section 201(h), Federal Food, Drug, and Cosmetic Act (Registration numbers available upon request.)
2. Compliance with the regulations of the Federal Trade Commission, as required under 15 U.S.C. §1451 (Fair Packaging and Labeling Act)

THERAID PAIN RELIEF CREAM

This product is proudly made in the United States of America and carries the National Drug Code numbers of 61577-5041-1, 61577-5041-2, 61577-5041-3, and 61577-5041-4.

It is manufactured through a privately held and FDA registered facility in full factory compliance with ISO9001:2008.

In addition, our foreign factories have met, and continues to meet or exceed, the international safety standards as certified by TUV Rheinland, including IEC 60601-1  (Medical Electrical Standards), EC 60601-1-2 (Electromagnetic Compatibility), EC 60601-2-35 (Safety Requirements – Medical Electrical Equipment), and full factory Management System Practices (ISO9001:2008)(Valid until June, 2012).

If you have any questions concerning our registrations, credentials, or testing, please feel free to contact our lead compliance officer, Dr. Barrett Weinberger at barry@therasage.com)