Flawless Motion Ltd

Flawless Motion Ltd specialises in shoulder braces, specifically the Flawless Motion Shoulder Brace. These devices are designed to provide support and stability for athletes or patients recovering from shoulder injuries or conditions by limiting excessive motion in multiple directions. The product line focuses solely on this single device type.

Flawless Motion Ltd is based in New Zealand. The company’s location is relevant for understanding its regulatory context, as it must ensure its devices comply with applicable New Zealand and international standards for market authorisation.

Flawless Motion Ltd’s devices are listed in the eudamed database, which is the European Union’s medical device registry. This registry tracks devices that have undergone the necessary conformity assessment procedures to meet EU regulatory requirements for market placement.

Flawless Motion Ltd’s shoulder braces are classified as Class I medical devices. This classification is determined based on their intended purpose and risk level, as defined by regulatory frameworks like the EU Medical Device Regulation (MDR). Class I devices typically pose the lowest risk and may require less stringent post-market surveillance compared to higher-risk categories.