The following data is part of a premarket notification filed by Rewalk Robotics Inc. with the FDA for Rewalk(tm).
| Device ID | K160987 |
| 510k Number | K160987 |
| Device Name: | ReWalk(TM) |
| Classification | Powered Exoskeleton |
| Applicant | REWALK ROBOTICS INC. 33 LOCKE DRIVE Marlborough, MA 01752 |
| Contact | John Hamilton |
| Correspondent | John Hamilton REWALK ROBOTICS INC. 33 LOCKE DRIVE Marlborough, MA 01752 |
| Product Code | PHL |
| CFR Regulation Number | 890.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-08 |
| Decision Date | 2016-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861803000303 | K160987 | 000 |