The following data is part of a premarket notification filed by Sunrise Medical (us) Llc with the FDA for Empulse R90.
| Device ID | K220213 |
| 510k Number | K220213 |
| Device Name: | Empulse R90 |
| Classification | Wheelchair, Powered |
| Applicant | Sunrise Medical (US) LLC 2842 N Business Park Ave. Fresno, CA 93727 |
| Contact | Devin Mcelroy |
| Correspondent | Devin Mcelroy Sunrise Medical (US) LLC 2842 N Business Park Ave. Fresno, CA 93727 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-26 |
| Decision Date | 2022-03-30 |