The following data is part of a premarket notification filed by Sunrise Medical, Inc. with the FDA for Quickie Qx Manual Folding Wheelchair.
Device ID | K072153 |
510k Number | K072153 |
Device Name: | QUICKIE QX MANUAL FOLDING WHEELCHAIR |
Classification | Wheelchair, Mechanical |
Applicant | SUNRISE MEDICAL, INC. 2842 BUSINESS PARK AVE. Fresno, CA 93727 |
Contact | Joseph E Olsavsky |
Correspondent | Joseph E Olsavsky SUNRISE MEDICAL, INC. 2842 BUSINESS PARK AVE. Fresno, CA 93727 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-03 |
Decision Date | 2007-09-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00016958053593 | K072153 | 000 |