Quantum Devices, Inc. – FDA Warning Letter

The FDA issued a Warning Letter to Quantum Devices, Inc. on July 11, 2012, for marketing the WARP 10 and WARP 75 LED Light Delivery System devices with unapproved indications. The WARP 10 (K032229) and WARP 75 (K113231) were cleared for over-the-counter use for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, stiffness, promoting muscle tissue relaxation, and temporarily increasing local blood circulation.

However, a review of the firm's website (www.qbmi.com) revealed claims representing major changes in intended use, including "treatment of mucositis in cancer patients," "pain management, accelerated wound healing, improvement in blood properties, and since-related diseases and disorders," "relief of pain from joint and muscle strains," and "relief of pain from joint inflammation."

These unapproved claims render the devices adulterated under Section 501(f)(1)(B) of the Act, as the firm lacks an approved premarket approval (PMA) application or an investigational device exemption. The devices are also misbranded under Section 502(o) for failure to notify the FDA of intent to introduce devices with these changes, as required by Section 510(k).

Quantum Devices is required to immediately cease marketing the devices for unapproved uses.