The following data is part of a premarket notification filed by Ekso Bionics, Inc. with the FDA for Eksonr.
| Device ID | K200574 |
| 510k Number | K200574 |
| Device Name: | EksoNR |
| Classification | Powered Exoskeleton |
| Applicant | Ekso Bionics, Inc. 1414 Harbour Way South, Suite 1201 Richmond, CA 94804 |
| Contact | Jack Peurach |
| Correspondent | Jack Peurach Ekso Bionics, Inc. 1414 Harbour Way South, Suite 1201 Richmond, CA 94804 |
| Product Code | PHL |
| CFR Regulation Number | 890.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-05 |
| Decision Date | 2020-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B168EKSONR0 | K200574 | 000 |