The following data is part of a premarket notification filed by Honda Motor Company, Ltd. with the FDA for Honda Walking Assist Device.
| Device ID | K181294 |
| 510k Number | K181294 |
| Device Name: | Honda Walking Assist Device |
| Classification | Powered Exoskeleton |
| Applicant | Honda Motor Company, Ltd. 1-4-1 Chuo Wako-shi, JP 351-0193 |
| Contact | Kazushi Hamaya |
| Correspondent | Mark Dipietro American Honda Motor Company, Inc. 4900 Marconi Drive Alpharetta, GA 30005 |
| Product Code | PHL |
| CFR Regulation Number | 890.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-16 |
| Decision Date | 2018-12-14 |
| Summary: | summary |