The following data is part of a premarket notification filed by Rewalk Robotics Ltd. with the FDA for Rewalk P6.0.
| Device ID | K200032 |
| 510k Number | K200032 |
| Device Name: | ReWalk P6.0 |
| Classification | Powered Exoskeleton |
| Applicant | ReWalk Robotics Ltd. 3 Hetnufa St., POB Box- 161 Yokneam, IL 2069203 |
| Contact | Ofir Koren |
| Correspondent | Ofir Koren ReWalk Robotics Ltd. 3 Hetnufa St., POB Box- 161 Yokneam, IL 2069203 |
| Product Code | PHL |
| CFR Regulation Number | 890.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-07 |
| Decision Date | 2020-05-26 |
| Summary: | summary |