Eve— 510(k) K260381
Substantially EquivalentWandercraft SAS
FDA 510(k) clearance K260381 for Eve, Substantially Equivalent on 2026-08-03. Applicant: Wandercraft SAS. Device class: 2.
Summary
Wandercraft's Eve is filed under product code PHL, powered exoskeletons. The record doesn't describe it beyond the name and that code.
Class II, 21 CFR 890.3480. The Neurology review panel handled it as a Traditional 510(k), though the record lists Physical Medicine as the classification panel.
Wandercraft filed from Paris, France. The substantially equivalent decision came 179 calendar days after receipt (February 5 to August 3, 2026).
Clearance details
- Applicant
- Wandercraft SAS
- Product code
- Product code PHL
- Device class
- Class 2
- Regulation
- 21 CFR 890.3480
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paris, FR
Recent devices under product code PHL
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