Our device can be classified under the following FDA device labels, each under Title 21,

Subchapter H – Medical Devices:

Part 888 – Orthopedic Devices

Subpart E – Surgical Devices

Section 888.5940 – Cast Component

- “…a device intended for medical purposes to protect or support a cast”

- Class I (general controls)

Part 890 – Physical Medicine Devices

Subpart D – Physical Medicine Prosthetic Devices

Section 890.3025 – Prosthetic and orthotic accessory

- “…a device intended for medical purposes to support, protect, or aid in the use of a cast, orthotics (brace), or prosthesis”

- Class I (general controls)

Part 890 – Physical Medicine Devices

Subpart F – Physical Medicine Therapeutic Devices

Section 890.5500 – Infrared lamp

- “… a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating”

- Class II (performance standards)

This device would be a Class I device that would require 510(k) approval.