Kunshan Aoshida Electric Technology Co., Ltd

Kunshan Aoshida Electric Technology Co., Ltd specializes in manufacturing attendant-controlled electric wheelchairs with powered steering. These devices are designed to assist users with mobility needs and include both non-collapsible models and examples like the FREED MCHVIR series, FREEDOMCHAIR, and A08 Power wheelchair. The focus is on powered mobility solutions for individuals requiring assistance.

The company is based in China, which means its devices must comply with both domestic Chinese regulations and international standards if marketed globally. While the company’s location influences regulatory pathways (e.g., conformity assessments, testing requirements, or market-specific approvals), individual devices—like the FREED MCHVIR or A08 Power wheelchair—are evaluated separately for compliance under frameworks such as EU MDR, FDA 510(k), or UDI listings.

Devices from Kunshan Aoshida are listed in key global regulatory databases, including eudamed (EU), FDA 510(k) pre-market notifications (US), and FDA UDI (Unique Device Identification) registries. These listings ensure traceability and compliance tracking for devices like the FREED MCHVIR or A08 Power wheelchair under their respective classification frameworks (Class I or Class II). Listing in these systems is required for market access in regulated regions.

The company’s electric wheelchairs are classified as Class I or Class II under regulatory schemes like the EU MDR or FDA. Classification determines the level of scrutiny and documentation required for market authorization. For example, Class II devices (e.g., powered mobility aids) typically require risk assessments, clinical evaluations, or post-market surveillance due to their higher risk profile compared to Class I items. This classification ensures patient safety and aligns with the device’s intended use and potential risks.