ReWalk(TM)— 510(k) K160987
Substantially EquivalentRewalk Robotics, Inc.
FDA 510(k) clearance K160987 for ReWalk(TM), Substantially Equivalent on 2016-07-22. Applicant: Rewalk Robotics, Inc.. Device class: 2.
Clearance details
- Applicant
- Rewalk Robotics, Inc.
- Product code
- Code PHL
- Device class
- Class 2
- Regulation
- 21 CFR 890.3480
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlborough, MA, US
Recent devices under product code PHL
view allRecalls naming K160987
K-number listed on FDA's recall record- Z-1553-2021 — ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.
- Z-0944-2018 — ReWalk Personal 6.0. Catalog number: 50-20-0004.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160987.
Data sourced from openFDA. This site is unofficial and independent of the FDA.