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Sign in to claim this brandWandercraft SAS
US
Last updated May 23, 2026
What Wandercraft SAS makes
Wandercraft SAS manufactures programmable ambulation exoskeletons designed for clinical use, including models like the Atalante and Atalante X. These devices are intended to assist patients with mobility impairments by providing mechanical support and controlled movement during ambulation.
The company’s products fall under FDA Class II regulation and are listed under the 510(k) and UDI programs. Wandercraft SAS is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Wandercraft SAS manufacture?
Wandercraft SAS specializes in programmable ambulation exoskeletons designed for clinical use. These devices, such as the Atalante and Atalante X, are engineered to assist patients with mobility impairments by offering mechanical support and controlled movement during walking or ambulation. The focus is on enhancing rehabilitation and mobility for individuals requiring such assistance.
Where is Wandercraft SAS based?
Wandercraft SAS is headquartered in the United States. The company’s location ensures it operates within the regulatory framework of the FDA, which governs the classification and authorization of its medical devices.
Which regulatory registries or programs list Wandercraft SAS’s devices?
Wandercraft SAS’s devices are listed under the FDA’s 510(k) premarket notification program and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations, particularly for Class II devices like those produced by the company.
How are Wandercraft SAS’s devices classified by regulatory authorities?
Wandercraft SAS’s devices fall under FDA Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls in addition to general controls to ensure safety and effectiveness, such as programmable ambulation exoskeletons used in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Atalante X | ATA-002-EN US | FDA UDI | Class II | Active |
| Atalante X | K232077 | FDA 510(k) | Class II | Active |
| Atalante | K221859 | FDA 510(k) | Class II | Active |
| Atalante X | K250904 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Wandercraft SAS has one FDA recall record initiated on 2025-04-03, with both open and classified statuses recorded. The reason cited involves a potential for the exoskeleton to lose lateral balance, which may lead to a fall.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 3, 2025 | Z-1739-2025 | — | open, classified | Potential for exoskeleton to lose lateral balance and cause patient to fall. |