K CARE HEALTHCARE SOLUTIONS PTY LTD

K Care Healthcare Solutions specializes in flotation therapy chairs, specifically designed for pressure relief and patient positioning. These devices are intended for clinical environments like hospitals and care facilities to assist patients who have limited mobility or require prolonged bed rest. The focus is on supporting comfort and reducing the risk of pressure ulcers through adjustable air cushioning.

K Care Healthcare Solutions is based in the United States. Since its devices are classified as Class I under FDA regulations, they fall under the general controls category, which requires compliance with FDA’s quality system regulations but does not require a premarket notification (510(k)) or premarket approval (PMA) unless additional risks are introduced. The U.S. location aligns with FDA’s jurisdiction over medical devices marketed in the country.

Yes, K Care Healthcare Solutions’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to verify the identity of the device, its manufacturer, and its compliance with FDA requirements. Listing in the UDI database is mandatory for Class I devices marketed in the U.S. to support post-market surveillance and recall management.

K Care Healthcare Solutions’ flotation therapy chairs are classified as Class I medical devices under FDA regulations. This classification is based on their intended use—providing pressure relief and patient positioning—which presents minimal potential risk to patients. Class I devices are subject to general controls, such as good manufacturing practices (GMP) and labeling requirements, but they do not require a premarket submission unless the device is modified to introduce new risks. The classification reflects the relatively low risk associated with these devices when used as intended.