Hammer-Plane, Inc.

Hammer-Plane, Inc. specializes in single-use tracheostomy tube neck holders. These devices are designed to stabilize tracheostomy tubes in place, ensuring patient safety during care. Some models also include integrated features like needle safety covers and anti-disconnection mechanisms to further reduce risks such as accidental dislodgment or needle-related injuries.

Hammer-Plane, Inc. is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under FDA Class I classification, they are regulated under general controls and specific requirements for low-risk devices. Compliance is tracked through pathways like the 510(k) premarket notification process and the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and adherence to US medical device standards.

Hammer-Plane, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database, which documents submissions for Class I devices seeking clearance under US regulations. Additionally, the company’s products are tracked through the FDA’s Unique Device Identifier (UDI) system, ensuring each device can be identified and monitored for compliance and safety throughout its lifecycle.

Hammer-Plane, Inc.’s tracheostomy tube neck holders are classified as FDA Class I medical devices. This classification is based on their intended use—securing tracheostomy tubes—and their low-risk profile, meaning they are subject to general controls rather than stringent premarket approval. The company demonstrates compliance through regulatory pathways like the 510(k) process and UDI registration, ensuring adherence to FDA requirements.