In April 2021, Shanghai Siyi Intelligent Technology Co., Ltd. announced its U.S. FDA establishment registration and device listings for specified Syrebo rehabilitation devices.
Registration and listing place the establishment and listed devices in the FDA's public database. For distributors, hospitals and clinical buyers, this provides a transparent reference for model-specific regulatory due diligence. The FDA states that registration and listing do not denote approval of the establishment or its products and are distinct from product-level 510(k) clearance or PMA approval.
Partners can search the official FDA Establishment Registration & Device Listing database and review the FDA's registration and listing guidance. Regulatory status varies by model, intended use and market, so current model-specific documentation should always be checked before a purchasing or distribution decision.
International rehabilitation procurement is rarely a one-document exercise. Clinical teams and distributors need a clear way to distinguish company-level registration, device listings, market-specific product authorization, quality-management records and the documentation attached to a particular model. Syrebo's approach is to make those distinctions explicit and provide current records for partner review.
Syrebo develops rehabilitation robotics around soft actuation, wearable design and multiple training modes. Depending on the model, the portfolio is designed to support passive, active-assisted, mirror and task-oriented practice across clinical and home-use scenarios. Device selection and training plans should be guided by a qualified rehabilitation professional and matched to the user's needs.
The 2021 announcement formed part of Syrebo's early international expansion. Since then, the company has continued developing rehabilitation solutions and supporting overseas partners with product information, training and model-specific documentation. The historical map below is retained as an archive illustration of the company's 2021 market outreach; it is not a statement of current service coverage.
Editor's note (updated July 24, 2026): The FDA public dataset checked on this date lists Shanghai Siyi Intelligent Technology Co., Ltd. under establishment registration No. 3018993530, with three device-listing records under product codes BXB, IKK and ISA. The dataset was last updated July 13, 2026. Registration and listing do not constitute FDA approval, clearance, certification or endorsement. Current status and model-specific requirements should be rechecked in the official database.
If you are evaluating Syrebo rehabilitation technology for a hospital, clinic or distribution partnership, explore our product portfolio and contact the Syrebo team for current specifications, regulatory documentation and implementation support.