ReWalk P6.0
FDA 510(k) clearance K221696 · decided 2023-03-02
Clearance details
- K-number
- K221696
- Device name
- ReWalk P6.0
- Applicant
- Re Walk Robotics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-10
- Decision date
- 2023-03-02
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- PHL
- Device class
- 2
- Regulation number
- 890.3480
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Yokneam, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.