Clearance Summary
ReWalk P6.0 received FDA 510(k) clearance under submission number K221696, sponsored by Re Walk Robotics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2023-03-02.
- Submission: K221696
- Applicant / Sponsor: Re Walk Robotics , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3480
- Decision date: 2023-03-02
Classification & Regulation
This clearance is catalogued under FDA product code PHL and 21 CFR 890.3480, within the Physical Medicine review panel as a Class II device.