Daeyang Medical Co., Ltd.

Daeyang Medical Co., Ltd. specializes in multi-modality physical therapy systems for professional medical use. These systems combine multiple therapeutic approaches, such as transcutaneous electrical nerve stimulation (TENS), to help manage musculoskeletal conditions. Examples include devices like the Back 3 COLOR, Winback Back 3SE, and TENSAMAX PRO+, which are designed for targeted pain relief and rehabilitation in clinical settings.

Daeyang Medical Co., Ltd. is based in the United States. The company focuses on developing and manufacturing its multi-modality physical therapy systems within this regulatory environment.

Daeyang Medical Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class II medical devices, ensuring transparency and compliance with U.S. regulatory requirements.

Daeyang Medical Co., Ltd.’s multi-modality physical therapy systems fall under Class II classification. This classification is determined based on the risk associated with the devices, where Class II devices generally pose moderate risks and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.