Eve
FDA 510(k) clearance K260381 · decided 2026-08-03
Clearance details
- K-number
- K260381
- Device name
- Eve
- Applicant
- Wandercraft SAS
- Decision
- Substantially Equivalent
- Date received
- 2026-02-05
- Decision date
- 2026-08-03
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- PHL
- Device class
- 2
- Regulation number
- 890.3480
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Paris, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Atalante X (K250904) | Wandercraft SAS | 2025-10-24 |
| ReWalk® 7 Personal Exoskeleton (50-20-0005) (K241822) | Rewalk Robotics Ltd. Dba Lifeward | 2025-03-12 |
| Medical HAL Lower Limb Type (HAL-ML) (K233695) | Cyberdyne, Inc. | 2024-05-07 |
| Atalante X (K232077) | Wandercraft SAS | 2023-12-13 |
| ReWalk P6.0 (K221696) | Re Walk Robotics , Ltd. | 2023-03-02 |
| Atalante (K221859) | Wandercraft SAS | 2022-12-29 |
| EksoNR (K220988) | Ekso Bionics, Inc. | 2022-06-09 |
| GEMS-H (K213452) | Samsung Electronics Co., Ltd. | 2022-04-21 |
| ExoAtlet-II (K201473) | Exoatlet Asia Co. , Ltd. | 2021-07-16 |
| HAL for Medical Use(Lower Limb type) (K201559) | Cyberdyne, Inc. | 2020-10-02 |
| Keeogo Dermoskeleton System (K201539) | B-Temia, Inc. | 2020-09-09 |
| EksoNR (K200574) | Ekso Bionics, Inc. | 2020-06-19 |
Recalls involving this device
No recalls on record reference this clearance.