FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Medical HAL Lower Limb Type (HAL-ML)
K Number: K233695
·
Decision May 7, 2024
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
23
Applicant Total
3
Review Days
172
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Basic Information
- Device Name
- Medical HAL Lower Limb Type (HAL-ML)
- K Number
- K233695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3480
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cyberdyne, Inc.
- Date Received
- November 17, 2023
- Decision Date
- May 7, 2024
- 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 |
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