The following data is part of a premarket notification filed by Sunrise Medical (us) Llc with the FDA for Quickie Pulse (models 6bc, 6sc, 6cc, 5bc, 5cc, 6mpc) And Zippie Zm-310 (models Bc, Sc).
| Device ID | K160031 |
| 510k Number | K160031 |
| Device Name: | Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) And Zippie ZM-310 (Models BC, SC) |
| Classification | Wheelchair, Powered |
| Applicant | SUNRISE MEDICAL (US) LLC 2842 BUSINESS PARK AV Fresno, CA 93727 |
| Contact | Laurie H Roberts |
| Correspondent | Laurie H Roberts SUNRISE MEDICAL (US) LLC 2842 BUSINESS PARK AV 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 | 2016-01-07 |
| Decision Date | 2016-07-14 |
| Summary: | summary |