The following data is part of a premarket notification filed by Sunrise Medical (us) Llc with the FDA for Quickie, Zippie.
Device ID | K142457 |
510k Number | K142457 |
Device Name: | Quickie, Zippie |
Classification | Wheelchair, Powered |
Applicant | Sunrise Medical (US) LLC 2842 Business Park Ave. Fresno, CA 93727 |
Contact | Laurie Roberts |
Correspondent | Laurie Roberts Sunrise Medical (US) LLC 2842 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 | 2014-09-02 |
Decision Date | 2014-12-18 |
Summary: | summary |