Atalante
FDA 510(k) clearance K221859 · decided 2022-12-29
Clearance details
- K-number
- K221859
- Device name
- Atalante
- Applicant
- Wandercraft SAS
- Decision
- Substantially Equivalent
- Date received
- 2022-06-27
- Decision date
- 2022-12-29
- Days to decision
- 185 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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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Eve (K260381) | Wandercraft SAS | 2026-08-03 |
| Atalante X (K250904) | Wandercraft SAS | 2025-10-24 |
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| Atalante X (K232077) | Wandercraft SAS | 2023-12-13 |
| ReWalk P6.0 (K221696) | Re Walk Robotics , Ltd. | 2023-03-02 |
| 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 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions an recall (Z-1739-2025) | WANDERCRAFT SAS | 2025-05-08 |