The following data is part of a premarket notification filed by Sunrise Medical (us) Llc with the FDA for Quickie(r) Q700-up M.
Device ID | K172384 |
510k Number | K172384 |
Device Name: | Quickie(r) Q700-UP M |
Classification | Wheelchair, Standup |
Applicant | Sunrise Medical (US) LLC 2842 Business Park Ave Fresno, CA 93727 |
Contact | Nancy J. Gertlar |
Correspondent | Nancy J. Gertlar Sunrise Medical (US) LLC 2842 Business Park Ave Fresno, CA 93727 |
Product Code | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-08 |
Decision Date | 2018-01-16 |
Summary: | summary |