ALOHA HOME HEALTH CARE SERVICES LLC

Aloha Home Health Care Services LLC specializes in disposable adult incontinence products. Specifically, they produce adult nappies under the CheekZ brand, which are designed for home health care use. These products are intended to manage incontinence for adults requiring such solutions.

The company is based in the United States. This location is relevant for understanding regulatory oversight, as the FDA governs medical devices manufactured there.

Aloha Home Health Care Services LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry helps track and identify medical devices for regulatory, safety, and quality purposes.

The company’s devices, including the CheekZ adult nappies, fall under FDA Class I classification. Class I devices are generally considered the lowest risk and often involve simple products like bandages or adult incontinence products, which pose minimal risk to users.