The following data is part of a premarket notification filed by Exoatlet Asia Co. Ltd. with the FDA for Exoatlet-ii.
| Device ID | K201473 |
| 510k Number | K201473 |
| Device Name: | ExoAtlet-II |
| Classification | Powered Exoskeleton |
| Applicant | ExoAtlet Asia Co. Ltd. 4582 S. Ulster Streer, Suite 205 Denver, CO 80237 |
| Contact | Bret Bostock |
| Correspondent | Allison C Komiyama AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego, CA 92110 |
| Product Code | PHL |
| CFR Regulation Number | 890.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-03 |
| Decision Date | 2021-07-16 |