FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Atalante X
K Number: K250904
·
Decision Oct 24, 2025
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
23
Applicant Total
3
Review Days
212
Basic Information
- Device Name
- Atalante X
- K Number
- K250904
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3480
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wandercraft SAS
- Date Received
- March 26, 2025
- Decision Date
- October 24, 2025
- Product Code
- PHL
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PHL | Powered Exoskeleton | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PHL), ordered by most recent decision date.
ReWalk® 7 Personal Exoskeleton (50-20-0005)
FDA 510(k)
FDA Class 2
·Physical Medicine
Medical HAL Lower Limb Type (HAL-ML)
FDA 510(k)
FDA Class 2
·Physical Medicine
Atalante X
FDA 510(k)
FDA Class 2
·Physical Medicine
ReWalk P6.0
FDA 510(k)
FDA Class 2
·Physical Medicine
Atalante
FDA 510(k)
FDA Class 2
·Physical Medicine
EksoNR
FDA 510(k)
FDA Class 2
·Physical Medicine